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 2020-02-05 for HAMMERLOCK 2 IMPLANT KIT 15X7MM/0 DEGREES/LARGE HL2L manufactured by Wrights Lane Synthes Usa Products Llc.
[178205052]
Patient id also reported as (b)(6). 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
[178205053]
It was reported that during a metatarsophalangeal joint arthrodesis on (b)(6) 2019, an expired hammerlock 2 implant kit was implanted in the patient. The issue was discovered when the circulating nurse looked at the sticker from the implant just before the patient woke up and realized that it was out of date. The surgeon immediately removed the hammer lock implant and replaced it with a hammertoe correction k-wire. He did not implant another hammer lock. The procedure was successfully completed with 15 minutes surgical delay. Patient was good. Concomitant devices: drill kit for hammer lock implant (part: dk-h2, lot: bdk180839, quantity: 1). This report is for a hammerlock 2 implant kit. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-00640 |
| MDR Report Key | 9670880 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-05 |
| Date of Report | 2019-12-12 |
| Date of Event | 2019-12-12 |
| Date Mfgr Received | 2020-02-05 |
| Device Manufacturer Date | 2014-10-22 |
| Date Added to Maude | 2020-02-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| 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 | HAMMERLOCK 2 IMPLANT KIT 15X7MM/0 DEGREES/LARGE |
| Generic Name | PIN, FIXATION, SMOOTH |
| Product Code | HTY |
| Date Received | 2020-02-05 |
| Model Number | HL2L |
| Catalog Number | HL2L |
| Lot Number | BMEHL145085B |
| Device Expiration Date | 2019-10-31 |
| 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 | 1. Required No Informationntervention | 2020-02-05 |