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 2018-05-09 for BONE SCREW 6.5X40 SELF-TAP N/A 00625006540 manufactured by Zimmer Manufacturing B.v..
[107707585]
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to being discarded by hospital. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical product: item # unknown, unknown cup, lot # unknown.
Patient Sequence No: 1, Text Type: N, H10
[107707586]
It was reported that during a total hip arthroplasty, the head of the screw fractured during insertion into the acetabulum. No adverse events have been reported as a result of the malfunction. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002648920-2018-00394 |
| MDR Report Key | 7497840 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-05-09 |
| Date of Report | 2019-02-14 |
| Date of Event | 2018-04-17 |
| Date Mfgr Received | 2019-02-13 |
| Device Manufacturer Date | 2018-04-02 |
| Date Added to Maude | 2018-05-09 |
| 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 SCREW 6.5X40 SELF-TAP |
| Generic Name | HIP PROSTHESIS |
| Product Code | NLF |
| Date Received | 2018-05-09 |
| Model Number | N/A |
| Catalog Number | 00625006540 |
| Lot Number | 63980985 |
| ID Number | (01) 00889024119840 |
| Operator | PHYSICIAN |
| 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 | 2018-05-09 |