MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-03-21 for WERBER COUNTERSINK CANNF.MIRCOCBSSCRS AO N/A 503004541 manufactured by Zimmer Gmbh.
[70420337]
The manufacturer received the device for investigation. The investigation is pending. Additional information has been requested and is currently not available. A cause for this specific event cannot be ascertained from the information provided. Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[70420338]
It was reported that a werber countersink cannf. Mircocbsscrs ao was used in a surgery on (b)(6) 2016. This product broke during surgery and a piece remained in patient's body. There is no medical intervention. No contributing conditions related to the event. The surgery was completed with another device. Additional information has been requested and is currently not available.
Patient Sequence No: 1, Text Type: D, B5
[109421799]
Trend analysis: a trend has been identified and an issue evaluation has been initiated. Event summary: it was reported that this product fell apart and stayed in body of patient. Review of received data no medical data such as x-rays, surgical notes or any other case-relevant documents received. Devices analysis visual examination: three broken instruments were returned for investigation. The broken pieces were not returned. It was reported that the broken pieces stayed in patient's body. On the returned instruments it can be seen that the tip is broken. The length of the broken tip is approximately 1mm. No further abnormalities can be detected. The outer diameter of the returned instruments was measured with a caliper. One instrument could not be measured as the breakage area is deformed and no meaningful measurement can be taken. For the other instruments the measurements are within the required specification. In addition, a functional check of the cannulation was done with inspection pins. The inner diameter (according to product drawing 1. 0 0/+0. 1) was tested with an inspection pin 1. 0 and inspection pin 1. 1. The inspection pin 1. 0 did pass in all three instruments whereas the inspection pin 1. 1 went not through the cannulation. The function of the inner diameter (cannulation) is therefore given. Conclusion summary the research department performed a hardness-test and a chemical analysis of 3 returned instruments. The investigations related to hardness showed that the material investigated is harder than it is supposed to be according to the drawing. The investigations from research department came to the conclusion that a material mix-up must have occurred at the supplier who was manufacturing the devices. The received raw material specification from the supplier describes that a material 1. 4028 was used. Research department also provided a conclusion that with a very high likelihood the used material for manufacturing was 1. 4112 (according to hardness-tests, chemical analysis and material-microstructure). Material 1. 4112 is a biocompatible medical grade stainless steel used e. G. For drill bits. However, corrective and preventive actions have already been initiated. Zimmer reference number of this file is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0009613350-2017-00417 |
| MDR Report Key | 6420244 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-03-21 |
| Date of Report | 2017-03-20 |
| Date of Event | 2016-08-25 |
| Date Mfgr Received | 2017-06-22 |
| Device Manufacturer Date | 2014-06-24 |
| Date Added to Maude | 2017-03-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KEVIN ESCAPULE |
| Manufacturer Street | 1800 WEST CENTER STREET |
| Manufacturer City | WARSAW IN 46580 |
| Manufacturer Country | US |
| Manufacturer Postal | 46580 |
| Manufacturer Phone | 8006136131 |
| Manufacturer G1 | ZIMMER GMBH |
| Manufacturer Street | SULZER ALLEE 8 SULZER INDUSTRIE PARK |
| Manufacturer City | WINTERTHUR 8404 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 8404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WERBER COUNTERSINK CANNF.MIRCOCBSSCRS AO |
| Generic Name | UNKNOWN |
| Product Code | HWW |
| Date Received | 2017-03-21 |
| Returned To Mfg | 2016-10-26 |
| Model Number | N/A |
| Catalog Number | 503004541 |
| Lot Number | 15350 |
| ID Number | 00889024111967 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER GMBH |
| Manufacturer Address | SULZER ALLEE 8 SULZER INDUSTRIE PARK WINTERTHUR 8404 SZ 8404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-21 |