MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-30 for TAMP HANDLE 03.670.205 manufactured by Wrights Lane Synthes Usa Products Llc.
[152939830]
Complainant part is not expected to be returned for manufacturer review / investigation. Device is not distributed in the united states, but is similar to device marketed in the usa. Gtin unavailable, product made prior to gtin compliance date without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed; no conclusion could be drawn. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[152939831]
It was reported that on (b)(6) 2019, the prodisc-c tamp, head of the instrument has broken off during a case. The surgeon used a bone tamp to final impact the device. It is unknown if there was a surgical delay. Patient and procedure outcome are unknown. This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2019-59453 |
| MDR Report Key | 8843274 |
| Date Received | 2019-07-30 |
| Date of Report | 2019-07-03 |
| Date of Event | 2019-07-03 |
| Date Mfgr Received | 2019-08-29 |
| Date Added to Maude | 2019-07-30 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | WERK H |
| Manufacturer Street | IM BIFANG 6 |
| Manufacturer City | HAEGENDORF 4614 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 4614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TAMP HANDLE |
| Generic Name | TAMP |
| Product Code | HXG |
| Date Received | 2019-07-30 |
| Catalog Number | 03.670.205 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-30 |