MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-10-04 for INSERTION JIG 125 DEGREE 1.5M N/A 211201210 manufactured by Zimmer Biomet, Inc..
[88159318]
Zimmer biomet complaint - (b)(4). Complaint sample was evaluated and the reported event was not confirmed. Product left conforming to print as there was no evidence that states otherwise. Per engineer,? The only thing that can be said is that they need to put the a/r guide in with the lag screw guide tube as described on page 20 of the attached surgical technique. If they follow this technique then they will see that there is resistance on the a/r guide tube.? Dhr was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no trends were identified. Investigation results concluded that the reported event was related to surgical technique. The condition is addressed in the surgical technique. 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
[88159319]
Insertion jig design.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2017-07852 |
| MDR Report Key | 6913564 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-10-04 |
| Date of Report | 2017-10-03 |
| Date of Event | 2015-01-05 |
| Date Mfgr Received | 2015-01-05 |
| Device Manufacturer Date | 2014-11-05 |
| Date Added to Maude | 2017-10-04 |
| 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 | INSERTION JIG 125 DEGREE 1.5M |
| Generic Name | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Product Code | LHX |
| Date Received | 2017-10-04 |
| Model Number | N/A |
| Catalog Number | 211201210 |
| Lot Number | CX2048C02 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-10-04 |