MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP PLATE 12 HOLES 163MM; PLATE, FIXATION, BONE

Model Number	223.621
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
Additional product codes: hwc, ktt.Complainant part is not expected to be returned for manufacturer review/investigation.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) 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 12-hole locking compression plate.This is report 2 of 7 for (b)(4).

• Brand Name: 3.5MM LCP PLATE 12 HOLES 163MM
• 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: 8196923
• Report Number: 2939274-2018-55574
• Device Sequence Number: 16210322
• Product Code: HRS
• UDI-Device Identifier: 10886982158031
• UDI-Public: (01)10886982158031
• 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: Other Health Care Professional
• Type of Report: Initial
• 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: 223.621
• Device Catalogue Number: 223.621
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 12/26/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Weight: 72