MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-12-02 for ORTHOSORB LS 1.3MM TPRD PN KIT N/A 110010745 manufactured by Biomet Orthopedics.
[32524752]
The product identification necessary to review manufacturing history was not provided. Current information is insufficient to permit a conclusion as to the cause of the event.
Patient Sequence No: 1, Text Type: N, H10
[32524753]
It was reported that patient underwent a bunionectomy on an unknown date. During the procedure, a saw was used to flush cut the pin. It was noted that the pin will break if it is pulled too hard. No additional information has been provided.
Patient Sequence No: 1, Text Type: D, B5
[35113121]
This follow-up report is being filed to relay corrected information.
Patient Sequence No: 1, Text Type: N, H10
[35113122]
It was reported that patient underwent a bunionectomy on (b)(6) 2015. During the procedure, a saw was used to flush cut the pin. It was noted that the pin will break if it is pulled too hard. No additional information has been provided.
Patient Sequence No: 1, Text Type: D, B5
[80147507]
This follow up report is being filed to relay corrected information.
Patient Sequence No: 1, Text Type: N, H10
[80147508]
It was reported that patient underwent a bunionectomy. During the procedure, the pin fractured, and a saw was used to flush cut the pin. It was noted that the pin will break if it is pulled too hard. No additional information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2015-04824 |
| MDR Report Key | 5261261 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-12-02 |
| Date of Report | 2015-12-15 |
| Date of Event | 2015-10-30 |
| Date Mfgr Received | 2015-11-15 |
| Date Added to Maude | 2015-12-02 |
| 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. MEGAN HAAS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743726700 |
| 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 | ORTHOSORB LS 1.3MM TPRD PN KIT |
| Generic Name | PIN, FIXATION |
| Product Code | OVZ |
| Date Received | 2015-12-02 |
| Model Number | N/A |
| Catalog Number | 110010745 |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-12-02 |