MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HAMMERLOCK2 IMPLANT 15X5 MM ANGLED; INTRAMEDULLARY BONE FASTENER

Model Number HL2MA

Device Problem Difficult to Open or Close (2921)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown.Date of event is unknown.Lot number is unknown.Device malfunctioned intra-operatively and was not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter phone number and email address are unavailable.Reporter is a synthes sales consultant.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).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.

Event Description

It was reported that on an unknown date, the surgeon had issues with a hammerlock 2 implant as it would push into the patient's proximal phalanx when the surgeon attempted to reduce the distal and proximal phalanx over the implant and push the phalanges together.The implant would just push in and not allow the distal phalanx to reduce properly.The implant was pulled out and the surgeon used a larger sized implant.Procedure outcome and patient outcome are unknown.This report is for a hammerlock2 implant 15x5 mm angled.This is report 1 of 1 for (b)(4).

• Brand Name: HAMMERLOCK2 IMPLANT 15X5 MM ANGLED
• Type of Device: INTRAMEDULLARY BONE FASTENER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES BME : SAN ANTONIO; 14785 omicron drive; #205; san antonio TX 78245
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7919682
• MDR Text Key: 122088002
• Report Number: 2939274-2018-53989
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00810633021477
• UDI-Public: (01)00810633021477
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HL2MA
• Device Catalogue Number: HL2MA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/05/2018
• Initial Date FDA Received: 09/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention