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 2017-09-28 for ORTHOSORB LS TAPERED PIN KIT N/A 110010745 manufactured by Zimmer Biomet, Inc..
[87878055]
(b)(4). (b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[87878056]
It was reported that during a knee surgery, the implant was found missing from package. However, the product had the correct k-wire. No adverse events have been reported as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2017-07425 |
| MDR Report Key | 6902457 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2017-09-28 |
| Date of Report | 2018-06-15 |
| Date of Event | 2017-09-05 |
| Date Mfgr Received | 2018-06-14 |
| Device Manufacturer Date | 2017-05-19 |
| Date Added to Maude | 2017-09-28 |
| 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 BIOMET, INC. |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHOSORB LS TAPERED PIN KIT |
| Generic Name | PIN, FIXATION, RESORBABLE, HARD TISSUE |
| Product Code | OVZ |
| Date Received | 2017-09-28 |
| Returned To Mfg | 2017-09-18 |
| Model Number | N/A |
| Catalog Number | 110010745 |
| Lot Number | 547840 |
| ID Number | SEE H10 |
| 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 BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-28 |