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 2018-03-30 for ORTHOSORB LS STRAIGHT PIN KIT N/A 110010741 manufactured by Zimmer Biomet, Inc..
[104044001]
(b)(4). The complaint device has been returned, but the device investigation has not yet been completed. Once the evaluation is completed, a supplemental medwatch will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[104044002]
It was reported that there was an orthosorb missing from the sterile package.
Patient Sequence No: 1, Text Type: D, B5
[113067215]
Complaint sample was evaluated and the reported event was not confirmed. Orthosorb kit components were returned for evaluation without the packaging (tray) of the kit. Dhr was reviewed and no discrepancies relevant to the reported event were found. Review of the complaint history determined that no further action is required. Without the opportunity to examine the packaging of the complaint product, the complaint cannot be confirmed and a definitive root cause cannot be determined. 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
| Report Number | 0001825034-2018-02274 |
| MDR Report Key | 7387072 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-03-30 |
| Date of Report | 2018-04-26 |
| Date of Event | 2018-02-16 |
| Date Mfgr Received | 2018-04-26 |
| Device Manufacturer Date | 2017-08-22 |
| Date Added to Maude | 2018-03-30 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 STRAIGHT PIN KIT |
| Generic Name | KNEE INSTRUMENT |
| Product Code | OVZ |
| Date Received | 2018-03-30 |
| Returned To Mfg | 2018-04-09 |
| Model Number | N/A |
| Catalog Number | 110010741 |
| Lot Number | 848720 |
| ID Number | (01) 00887868130793 |
| 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 | 2018-03-30 |