MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 3.5MM LCP® MEDIAL DISTAL TIBIA PLATE W/O TAB 10 HOLES-LEFT; PLATE, FIXATION, BONE

Model Number	238.707
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier, age or date of birth, and weight not available for reporting.Date of event: date of device breakage is not known.Implanted date: date of implant reported as approximately two (2) months prior to explant.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.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 revision surgery was performed on (b)(6) 2017.The patient was implanted with a 3.5mm locking compression plate (lcp) medial distal tibia plate approximately two months prior to removal and, per the surgeon, was non-compliant and the plate broke.The patient was revised to a similar plate.Surgery completed successfully with no delay.Concomitant devices reported: screws (part number unknown, lot number unknown, quantity unknown).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Dhr review was completed.Part number: 238.707 lot number: 6836135 part mfg date: 16-dec-2011 part exp.Date: n/a (for sterile product) manufacturing location: (b)(4).Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 3.5mm lcp medial distal tibia plates was processed through the normal manufacturing and inspection operations with no non-conformance 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.The review of the raw material device history record revealed this lot met all specifications with no non-conformance noted.This raw material 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.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® MEDIAL DISTAL TIBIA PLATE W/O TAB 10 HOLES-LEFT
• 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: 7161610
• Report Number: 2939274-2018-50062
• Device Sequence Number: 1497869
• Product Code: HRS
• UDI-Device Identifier: 10886982162175
• UDI-Public: (01)10886982162175(10)6836135
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K013248
• 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,Followup
• Report Date (Section B): 12/07/2017

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: 238.707
• Device Catalogue Number: 238.707
• Device Lot Number: 6836135
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 02/02/2018
• 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