MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP RECONSTRUCTION PLATE 12 HOLES/168MM; APPLIANCE, FIXATION, NAIL

Model Number	245.121
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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, the patient underwent removal of a posterolateral distal humerus plate and a 3.5 locking compression plate (lcp) reconstruction plate due to nonunion.There was one 3.5 locking compression plate (lcp) reconstruction plate was broken.Also, 3.5 locking screw broke during removal.All hardware was removed except for the fragment of the broken locking screw.A stryker plate was used to revise.The date of the original implant was on (b)(6) 2018.There was no surgical delay.Procedure outcome and the patient consequence were unknown.Concomitant device reported: 3.5 lcp distal humerus plate (part # 02.104.008, lot # unknown, quantity 1); unknown cortex screw (part # unknown, lot # unknown, quantity 7); unknown locking screw (part # unknown, lot # unknown, quantity 4); this report is for one (1) 3.5mm lcp reconstruction plate 12 holes/168mm.This is report 1 of 1 for (b)(4).This complaint captures the post-operative event where the plate broke post-operatively while (b)(4) captures the intra-operative event where the screw broke during removal.

• Brand Name: 3.5MM LCP RECONSTRUCTION PLATE 12 HOLES/168MM
• Common Device Name: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8759161
• Report Number: 2939274-2019-59013
• Device Sequence Number: 2040226
• Product Code: KTT
• UDI-Device Identifier: 10886982169686
• UDI-Public: (01)10886982169686
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: K000684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 06/07/2019

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: 245.121
• Device Catalogue Number: 245.121
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 07/03/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.5MM LCP EXTRA-ARTICLR DISTAL; UNK - SCREWS: CORTEX; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Weight: 63