MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP PLATE 6 HOLES 85MM; PLATE, FIXATION, BONE

Model Number	223.561
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Date of post-operative infection development is unknown.Additional device product codes: hwc, ktt.Complainant device is not expected to be returned for manufacturer review/investigation.A review of the device history records has been requested and is currently pending completion.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a patient had original surgery performed on (b)(6) 2014.Patient was revised on (b)(6) 2015 due to non-union.The patient was revised again on (b)(6) 2018 due to nonunion of humerus and one broken 4.0mm locking screw.During revision surgery the head of the broken screw was removed and the shaft of the screw was left inside the patient.Also, one (1) 4.5mm narrow lcp plate 8 holes/152mm, three (3) 4.5mm cortex screws, three (3) 3.5mm cortex screws, one (1) 3.5mm lcp plate 6 holes 85mm, two (2) 3.5mm locking screws and two (2) 4.0mm locking screws were removed intact.The fracture ends were shortened and the patient was replated with a 7 hole 4.5mm broad plate (vivigen bone graft).The revision surgery was successfully completed without any delay and without any other medical intervention required.Patient was reported to be okay after the surgery.Later, it was informed by the hospital that the intra-op cultures came back positive from the day of surgery.The doctor has decided to use antibiotics for treatment of the infection.This report addresses second revision surgery due to broken screw and infection.The first revision surgery due to non-union has been captured under linked complaint (b)(4).This report is for one (1) 3.5mm lcp plate 6 holes 85mm.This is report 4 of 7 for complaint (b)(4).
Additional Manufacturer Narrative
A device history record (dhr) review: part number: 223.561, lot number: 7886910 part manufacturing date: 5 january 2015 manufacturing site: (b)(4) part expiration date: n/a nonconformance noted: n/a: a review of the device history record (dhr) revealed no nonconformances.The dhr shows lot# 6498488 of 4.5mm narrow lcp plate 8 holes/152mm was processed through the normal manufacturing and inspection operations with no non-conformances or rework noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material dhr revealed this lot met all specifications with no nonconformances or rework noted.A review of the raw material device history record(s) determined the raw material lot 7744601 met all specifications with no issues documented that would contribute to this complaint condition.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.

• Brand Name: 3.5MM LCP PLATE 6 HOLES 85MM
• 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: 7287471
• Report Number: 2939274-2018-50719
• Device Sequence Number: 11091998
• Product Code: HRS
• UDI-Device Identifier: 10886982157911
• UDI-Public: (01)10886982157911(10)7886910
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 223.561
• Device Catalogue Number: 223.561
• Device Lot Number: 7886910
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 03/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Weight: 90