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 2020-03-27 for JUGGERSTITCH STRAIGHT IMPLANT N/A 110024772 manufactured by Zimmer Biomet, Inc..
[185566170]
(b)(4). (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[185566171]
It was reported, during a meniscus repair, the inserter on a straight juggerstitch broke during implantation. The inserter had the metal needle that surrounds the tip that extends past the plastic depth gauge broke off in the back of the meniscus as the first implant was being deployed. The inserter was previously slightly bent when going into the knee by the femoral condyle. The malfunction was noticed after the implants were in and the surgeon was scrubbed out but before the patient was woken up and taken off the table. The surgeon scrubbed back in and could feel the metal on the lateral side of the knee. He made a small stab incision and pulled out the metal piece, roughly 25 mm long, out of the back of the knee. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2020-01325 |
| MDR Report Key | 9888850 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-08-02 |
| Date Added to Maude | 2020-03-27 |
| 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 | NI |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JUGGERSTITCH STRAIGHT IMPLANT |
| Generic Name | FASTENER, FIXATION |
| Product Code | MBI |
| Date Received | 2020-03-27 |
| Model Number | N/A |
| Catalog Number | 110024772 |
| Lot Number | 191960 |
| 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 | 2020-03-27 |