MAUDE Adverse Event Report: SYNTHES USA 2.0MM LCP (TM) CONDYLAR PLATE 7 HOLES SHAFT; PLATE, FIXATION, BONE

Catalog Number	247.349
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional patient information: patient's height is (b)(6).Patient identifier, date of birth is not available for reporting.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Part 247.349 lot l121320 is not a valid part and lot combination.Therefore device history record (dhr) review could not be performed.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 revision surgery was completed on (b)(6) 2017 due to a broken plate and non-union.The patient was originally implanted with the devices on (b)(6) 2016.A broken plate, two intact locking screws and 5 intact cortex screws were successfully removed.The revision surgery was an open reduction internal fixation (orif) of a second metacarpal.Patient was revised to a locking compression plate (lcp) with vivigen bone graft.The procedure was successfully completed with no delays or harm to patient.Concomitant devices reported: locking screw (part # unknown, lot # unknown, quantity 2), cortex screw (part # unknown, lot # unknown, quantity 5).This is report 1 of 1 for complaint (b)(4).

• Brand Name: 2.0MM LCP (TM) CONDYLAR PLATE 7 HOLES SHAFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 6413058
• Report Number: 2520274-2017-10914
• Device Sequence Number: 658827
• Product Code: HRS
• UDI-Device Identifier: 10886982170750
• UDI-Public: (01)10886982170750(10)L121320
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K063049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/23/2017

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 Catalogue Number: 247.349
• Device Lot Number: L121320
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2017
• Initial Report FDA Received Date: 03/17/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CORTEX SCREW (PART AND LOT # UNKNOWN, QTY 5); LOCKING SCREW (PART AND LOT # UNKNOWN, QTY 2)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Weight: 82