MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2017-07-06 for TOGGLELOC/WASHERLOC DISPOSABLE KIT N/A 909846 manufactured by Biomet Sports Medicine.
[79228690]
Pt identifier: - (b)(6). Device product code - kdd. Udi number - (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. 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
[79228691]
It has been reported that during an acl reconstruction procedure, metal shavings were noticed in the knee joint after using the 2. 4mm drill tip pin from the kit. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
[109655377]
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. 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
[109655378]
It has been reported that during an acl reconstruction procedure, metal shavings were noticed in the knee joint after using the 2. 4mm drill tip pin from the kit. It is unknown if all metal shavings were successfully removed.
Patient Sequence No: 1, Text Type: D, B5
[120163637]
The complaint sample was evaluated, but the reported event could not be confirmed. The device history records were reviewed and no deviations relevant to the reported event were identified. A complaint history search was performed and no actions are required. A root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2017-04225 |
| MDR Report Key | 6691018 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-07-06 |
| Date of Report | 2018-01-06 |
| Date of Event | 2017-06-08 |
| Date Mfgr Received | 2018-01-06 |
| Device Manufacturer Date | 2017-05-07 |
| Date Added to Maude | 2017-07-06 |
| 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 | 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 | TOGGLELOC/WASHERLOC DISPOSABLE KIT |
| Generic Name | KIT, SURGICAL INSTRUMENT, DISPOSABLE |
| Product Code | KDD |
| Date Received | 2017-07-06 |
| Model Number | N/A |
| Catalog Number | 909846 |
| Lot Number | 318780 |
| 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 | 1. Other | 2017-07-06 |