MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2018-08-07 for BONE SCR 6.5X30 SELF-TAP N/A 00625006530 manufactured by Zimmer Manufacturing B.v..
[116212350]
(b)(4). Customer indicated that device will not be returned as it was discarded by hospital. (b)(4). Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. Reported event was unable to be confirmed due to limited information received from the customer. This device and event was previously reported on 0001822565-2017-08650. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[116212351]
It was reported that during a hip procedure, the screw fractured during insertion and a piece was left in the patient. Attempts have been made and additional information on the reported event is unavailable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002648920-2018-00552 |
| MDR Report Key | 7756334 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-08-07 |
| Date of Report | 2018-12-10 |
| Date of Event | 2017-11-27 |
| Date Mfgr Received | 2018-12-10 |
| Device Manufacturer Date | 2017-10-02 |
| Date Added to Maude | 2018-08-07 |
| 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 | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER MANUFACTURING B.V. |
| Manufacturer Street | TURPEAUX INDUSTRIAL PARK ROUTE #1 KM 123.4 BLDG #1 |
| Manufacturer City | MERCEDITA PR 00715 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00715 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BONE SCR 6.5X30 SELF-TAP |
| Generic Name | PROSTHESIS, HIP |
| Product Code | NLF |
| Date Received | 2018-08-07 |
| Model Number | N/A |
| Catalog Number | 00625006530 |
| Lot Number | 63794447 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER MANUFACTURING B.V. |
| Manufacturer Address | TURPEAUX INDUSTRIAL PARK ROUTE #1 KM 123.4 BLDG #1 MERCEDITA PR 00715 US 00715 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-07 |