MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI LCP WRIST FUSION STANDARD BEND PLATE; PLATE, FIXATION, BONE

Model Number	04.110.150
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Arthritis (1723); Swelling (2091); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.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.
Event or Problem Description
It was reported that on (b)(6) 2019, patient underwent removal of one (1) titanium locking compression plate (lcp) wrist fusion standard bend plate and eight (8) unknown locking screws.There was a failure of the locking screws over the 3rd metacarpal.The screws had failed at the head shaft junction.The metal plate had lifted itself off the 3rd metacarpal and was prominent over the dorsal aspect of the right hand and four (4) unknown locking screws were broken.Extensive adhesions were present between the subcutaneous tissues and extensor tendons.A swelling and prominence were noted over the dorsal aspect of the 3rd metacarpal where the lcp standard bend plate had disengaged from the 3rd metacarpal.There was no surgical delay.Procedure outcome was successful.Patient status is unknown.Concomitant device reported: unknown locking screws (part #: unknown, lot #: unknown, quantity #: 4).This is report 1 of 5 for (b)(4).

• Brand Name: TI LCP WRIST FUSION STANDARD BEND PLATE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8884258
• Report Number: 2939274-2019-59709
• Device Sequence Number: 11374538
• Product Code: HRS
• UDI-Device Identifier: 10886982100320
• UDI-Public: (01)10886982100320
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K042355
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2019

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
• Operator of Device: Health Professional
• Device Model Number: 04.110.150
• Device Catalogue Number: 04.110.150
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 08/12/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 79