MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP PLATE 10 HOLES 137MM; PLATE, FIXATION, BONE

Model Number	223.601
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional pro-codes: hwc, ktt.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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 an unknown date, the patient underwent a hardware removal due to nonunion.Originally, the patient was implanted with the locking compression plate (lcp) system on an unknown date.The lcp plates and the unknown screws were removed successfully.The surgeon commented that the fracture has been infected for approximately six (6) years and has been revised multiple times.Patient outcome was unknown.(b)(4) captures the 10 of 16 devices and (b)(4) captures the 7 of 17.This report is 1 of 10 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: b5: concomitant product update.H3, h6: investigation summary.Product was not returned.Reviewing attached picture, the nonunion and screw migration can be observed.No other product problem could be identified.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 history lot: null.Device history batch: null.Device history review: null.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
Concomitant product update: 3.5mm lcp plate 10 holes 137 mm ( unknown part#:, quantity # 1).4.5mm narrow lcp® plate 10 holes/188mm ( unknown part #, quantity # 1).Unk - screws: locking ( unknown part#:, quantity#: 1).Unk - screws: cortex ( unknown part#:, quantity#: 3).Unk - screws: trauma ( unknown part#:, quantity#: 4).

• Brand Name: 3.5MM LCP PLATE 10 HOLES 137MM
• 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: 9851125
• Report Number: 2939274-2020-01336
• Device Sequence Number: 740807
• Product Code: HRS
• UDI-Device Identifier: 10886982157997
• UDI-Public: (01)10886982157997
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 223.601
• Device Catalogue Number: 223.601
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 04/14/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.5MM LCP PLATE 10 HOLES 137MM; 4.5MM NARROW LCP® PLATE 10 HOLES/188MM; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: LOCKING; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 97