MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-01-06 for COMBO TRAY ADJUSTABLE TIBIAL TAMP HEAD, NET SHAPE 213-75-01 manufactured by Exactech, Inc.
[35159143]
The engineering evaluation noted that the experience reported was likely the result of excessive force un impaction, which lead to a brittle fracture of the locking feature. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[35159144]
The impact head broke at the modular portion. The keel head was unable to extracted from the proximal tibial bone. This event occurred outside of the us.
Patient Sequence No: 1, Text Type: D, B5
[73478180]
The engineering evaluation noted that the experience reported was likely the result of excessive force on impaction, which lead to a brittle fracture of the locking feature. Exactech confirmed that no pieces of the device were left in the patient.
Patient Sequence No: 1, Text Type: N, H10
[73478181]
The impact head broke at the modular portion. The keel head was unable to extracted from the proximal tibial bone. This event occurred outside of the us.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038671-2016-00023 |
| MDR Report Key | 5347305 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-01-06 |
| Date of Report | 2017-04-04 |
| Date of Event | 2015-02-04 |
| Date Mfgr Received | 2015-02-04 |
| Date Added to Maude | 2016-01-06 |
| 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 | MR GRAHAM CUTHBERT |
| Manufacturer Street | 2320 NW 66TH CT |
| Manufacturer City | GAINESVILLE FL 32653 |
| Manufacturer Country | US |
| Manufacturer Postal | 32653 |
| Manufacturer Phone | 3523771140 |
| Manufacturer G1 | EXACTECH, INC |
| Manufacturer Street | 2320 NW 66TH CT |
| Manufacturer City | GAINESVILLE FL 32653 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32653 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMBO TRAY ADJUSTABLE TIBIAL TAMP HEAD, NET SHAPE |
| Generic Name | TIBIAL TAMP HEAD |
| Product Code | HXG |
| Date Received | 2016-01-06 |
| Catalog Number | 213-75-01 |
| Lot Number | 61872001 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EXACTECH, INC |
| Manufacturer Address | 2320 NW 66TH CT GAINESVILLE FL 32653 US 32653 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-01-06 |