MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for SPEEDTITAN COMPRESSION IMPLANT KIT 15X15MM SE-1515TI manufactured by Wrights Lane Synthes Usa Products Llc.
[185908357]
Complainant part is not expected to be returned for manufacturer review/investigation. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[185908358]
It was reported that on march 4, 2020, during an unknown procedure, the implant insertion device was found to be broken in the box. There was no visible damage to the outside of the box. The broken implant insertion devices were not used on the patient and a new one was opened. The broken implant insertion devices were found while the patient was under anesthesia. The procedure and patient outcome are unknown. Concomitant devices reported: speedtitan compression implant kit 15x15mm (part number se-1515ti, lot bse170107, quantity 1). This report involves one (1) speedtitan compression implant kit 15x15mm. This is report 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01620 |
| MDR Report Key | 9904482 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-31 |
| 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 | SYNTHES BME : SAN ANTONIO |
| Manufacturer Street | 14785 OMICRON DRIVE #205 |
| Manufacturer City | SAN ANTONIO TX 78245 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78245 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPEEDTITAN COMPRESSION IMPLANT KIT 15X15MM |
| Generic Name | BONE STAPLE |
| Product Code | JDR |
| Date Received | 2020-03-31 |
| Catalog Number | SE-1515TI |
| Lot Number | BSE181239 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-31 |