MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM LCP PROXIMAL TIBIA PLATE 14 HOLES/262MM-RIGHT; PLATE, FIXATION, BONE

Model Number	240.046
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.A review of the device history records has been requested.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) 2018, the patient underwent a hardware removal of one (1) unknown 3.5 mm locking screw that was broken and one (1) unknown 5mm cannulated locking screw that was cold welded to 4.5mm locking compression plate (lcp) proximal tibia plate 12 holes/226mm left due to infection.The plate had to be cut away to remove the screw.All implants including three (3) unknown 5.0 mm cannulated screws, six (6) unknown locking screws, four (4) unknown cortex screws, (1) unknown locking screw, and one (1) unknown cannulated screw were removed successfully.There was difficulty removing the fragments that were generated from the broken device and trephine was used to remove the screw head.Original implantation was on (b)(6) 2015, for an open reduction and internal fixation (orif) of the proximal tibia.The procedure was completed successfully.There was no surgical delay.The patient outcome was stable.This complaint captures the post-operative infection and broken screws.The intra-operative event involving the plate being cut away is captured under related complaint (b)(4).This report is for a proximal tibia plate-right.This is report 1 of 7 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.Part manufacture date: december 26, 2012 ; part exp.Date: n/a; manufacturing location: depuy synthes ¿ elmira ; lot: 7138154 ; part: 240.046 a review of the device history record (dhr) revealed no non-conformances.The dhr shows lot 7138154 of 4.5mm lcp proximal tibia plate 14 holes/262mm-right 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 non-conformances or rework noted.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: 4.5MM LCP PROXIMAL TIBIA PLATE 14 HOLES/262MM-RIGHT
• 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: 8196813
• Report Number: 2939274-2018-55573
• Device Sequence Number: 13994734
• Product Code: HRS
• UDI-Device Identifier: 10886982164636
• UDI-Public: (01)10886982164636
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K052390
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2018

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: 240.046
• Device Catalogue Number: 240.046
• Device Lot Number: 7138154
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 12/26/2018
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 01/18/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Weight: 72