MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-07-27 for BIPASS DISPOSABLE PUSHER SINGLE PACK ABS/NITINOL N/A 902093 manufactured by Biomet Sports Medicine.
[81185444]
(b)(4). The customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[81185445]
It is reported that during a surgical procedure to repair a rotator cuff, the nitinol pusher would not pass the suture through the rotator cuff after several attempts. Attempts have been made to retrieve additional information, but no further information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2017-05202 |
| MDR Report Key | 6747301 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-07-27 |
| Date of Report | 2017-11-09 |
| Date Mfgr Received | 2017-11-08 |
| Device Manufacturer Date | 2016-12-04 |
| Date Added to Maude | 2017-07-27 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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 | BIOMET ORTHOPEDICS |
| 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 | BIPASS DISPOSABLE PUSHER SINGLE PACK ABS/NITINOL |
| Generic Name | FASTENER, FIXATION |
| Product Code | HXO |
| Date Received | 2017-07-27 |
| Model Number | N/A |
| Catalog Number | 902093 |
| Lot Number | 399320 |
| ID Number | SEE H10 NARRATIVE |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET SPORTS MEDICINE |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-27 |