MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 3.5MM LCP® METAPHYSEAL PLATE 11 HOLES; APPLIANCES, FIXATION, NAIL/BLD/PL COMBO, MULTI COMP, METAL COM

Model Number	223.411
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Unspecified Infection (1930); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is unknown.It is unknown when the event occurred.510k: this report is for 1 (one) 3.5 mm lcp metaphyseal plate/unknown lot.Lot number is unknown.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.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 the patient underwent revision of a plate and screws on (b)(6) 2017 due to broken plate, non-union, and septic infection.The patient presented with a broken 3.5 mm locking compression plate (lcp) metaphyseal plate, 11 hole plate in the left mid-shaft ulna.The original implant date is unknown.The plate and nine (9) screws (six (6) 3.5 mm cortex screws in the plate, one (1) independent lag screw, and two (2) 3.5 mm locking screws) were successfully removed, there were no fragments.A chisel was used to remove bone growth from over the screws and plate.The area was debrided and irrigated.A new plate was implanted; the surgeon cut the proximal tip of the plate to accommodate the patient anatomy.Relevant screws were used for fixation: variable angle elbow set and lcp small fragment set.The procedure was successfully completed.This report is for a 3.5 mm lcp metaphyseal plate.(b)(4).

• Brand Name: 3.5MM LCP® METAPHYSEAL PLATE 11 HOLES
• Common Device Name: APPLIANCES, FIXATION, NAIL/BLD/PL COMBO, MULTI COMP, METAL COM
• Manufacturer (Section D): WRIGHTS LANE: SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7130842
• Report Number: 2939274-2017-50377
• Device Sequence Number: 1358886
• Product Code: LXT
• UDI-Device Identifier: 10886982157638
• UDI-Public: (01)10886982157638(10)UNKNOWNLOT
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K033805
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/23/2017

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: 223.411
• Device Catalogue Number: 223.411
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/23/2017
• Initial Report FDA Received Date: 12/19/2017
• 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: 43 YR