MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,foreign,health professi report with the FDA on 2015-05-26 for ALLOFIT ALLOCLASSIC SHELL 58/LL 4248 manufactured by Zimmer Gmbh.
[5883047]
It was reported that during operation prof. (b)(6) recognized a hole in the steril plastic bag and did not use the allofit cup because of risk of contamination.
Patient Sequence No: 1, Text Type: D, B5
[13409053]
The manufacturer did not receive devices, photos or other source documents for review. The device history records were reviewed and found to be conforming. A cause for this specific event cannot be ascertained from the info provided. Should add'l info become available and an investigation result be available, that change this assessment, an amended medical device report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[75649455]
Possible causes for the reported event according to dfmea. Bag was not tight , product not completely protected from environment , part not fixed in vacuumized bag, burst of bag welding, not tight sterile barrier, due to confusion with router paper, error during handwriting when scanner was broken. Not possible as router paper for lot 2780701 did not state any error related to that. Not visible vacuumized product, not fixed in the vacuumized bag, delay of surgery, due to damaged vacuum machine. Not possible as the vacuum welding was completely intact. Bag was not tight (ivp/avp), sterile barrier affected, due to hair in the contact area between two polymer layers: not possible as no part was found to be in contact with the layer. Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue. Our investigation and our production records did not indicate any incidents during manufacturing process. The review of the device history records showed that the device was manufactured, washed and packaged according to defined specs with no reported non-conformities regarding the sterile barrier. The need for corrective measures is not indicated at this point of time and zimmer (b)(4) considers this case as closed.
Patient Sequence No: 1, Text Type: N, H10
[75649456]
Additional information received on july 28, 2015. It was reported that during surgery a hole in the sterile plastic bag was detected. The affected device was returned for investigation. The visual examination confirmed the reported error pattern. A hole in the sterile packaging could be seen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9613350-2015-00616 |
| MDR Report Key | 4798270 |
| Report Source | 01,05,FOREIGN,HEALTH PROFESSI |
| Date Received | 2015-05-26 |
| Date of Report | 2015-05-07 |
| Date of Event | 2015-05-07 |
| Date Mfgr Received | 2015-05-07 |
| Device Manufacturer Date | 2014-11-01 |
| Date Added to Maude | 2015-06-23 |
| 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 | KEVIN ESCAPULE |
| Manufacturer Street | PO 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 | ALLOFIT ALLOCLASSIC SHELL 58/LL |
| Generic Name | ALLOFIT ALLOCLASSIC SHELL 58/LL |
| Product Code | KWB |
| Date Received | 2015-05-26 |
| Returned To Mfg | 2015-05-19 |
| Catalog Number | 4248 |
| Lot Number | 2780701 |
| Device Expiration Date | 2019-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER GMBH |
| Manufacturer Address | SULZER ALLEE 8 WINTERTHUR 8404 SZ 8404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-26 |