MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2015-11-27 for TWIST DR 25X95MM CANN 12MM THD 30MM AO 502015621 manufactured by Normed Medizin-technik Gmbh.
[32196191]
Where lot numbers were received for the device, the device history record were reviewed and found to be conforming. The device is in transit to zimmer (b)(4) and will be investigated. A cause for this specific event cannot be ascertained from the information provided. As soon as supplemental information and investigation results becomes available an updated report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[32196192]
It was reported, during kit inspection it was recognized that the cannulated drill did not drill the cannulation as intended. Notes: the implantation and explantation dates are left empty as the device involved in this complaint is an instrument. Hence, no expiration date is captured, for the same reason.
Patient Sequence No: 1, Text Type: D, B5
[44051700]
It was reported, during kit inspection it was recognized that the cannulated drill did not drill the cannulation as intended. No trend identified. The compatibility check could not be performed as only one product was reported to us. The product compatibility check is not relevant for one product only. The device manufacturing quality records indicate that the released components met all requirements to perform as intended. The two cannulated twist drills were returned for investigation. The visual examination showed no abnormalities on the outer side of the device. The inner diameter (cannulation) is completely drilled through the device and did not show any conspicuousness by visual examination. A functional test was performed, both cannulated drills were tested with test pins. The results of the functional test are as following: the test pin with diameter 1. 2mm did not pass in the cannulation of both devices. A smaller diameter test pin (1. 15mm) was tested. This test pin just passed in the cannulation. This confirmed that the cannulation is complete, but too small for the 1. 2 k-wire. Possible causes for the reported event according to rmw: a. Wire does not pass through the device due to failure of instrument mating condition. B. Wire does not pass through the device due to inadequate design for intended handling performance. Comparison to investigation results whether it is possible and justification: a. Possible: the functional test showed that it was not possible to insert the appropriate 1. 2 k-wire through the device. B. Possible: the functional tests evidenced that the cannulation is complete, but too small for the 1. 2 diameter pins.. Based on the given information and the results of the investigation, we could identify a root cause for this issue. The cannulation of the device is smaller than 1. 2mm. An issue investigation has been initiated. The need for corrective actions is not indicated at this point of time and zimmer (b)(4) considers this case as closed. Zimmer's reference number of this file is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9613350-2015-01913 |
| MDR Report Key | 5252786 |
| Report Source | FOREIGN |
| Date Received | 2015-11-27 |
| Date of Report | 2015-11-04 |
| Date of Event | 2015-11-04 |
| Date Mfgr Received | 2016-04-27 |
| Device Manufacturer Date | 2014-07-25 |
| Date Added to Maude | 2015-11-27 |
| 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 | P.O. BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 5742676131 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TWIST DR 25X95MM CANN 12MM THD 30MM AO |
| Generic Name | TWIST DR |
| Product Code | HTT |
| Date Received | 2015-11-27 |
| Returned To Mfg | 2015-12-08 |
| Catalog Number | 502015621 |
| Lot Number | 14941 |
| Operator | SERVICE PERSONNEL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NORMED MEDIZIN-TECHNIK GMBH |
| Manufacturer Address | ULRICHSTRASSE 7 TUTTLINGEN, 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-11-27 |