MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 3.5MM LCP RECONSTRUCTION PLATE 7 HOLES/98MM; APPLIANCE,FIXATION,NAIL

Model Number	245.071
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight not available for reporting.Date of non-union and bent plate is not known.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.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 patient was implanted with a 3.5 mm locking compression plate (lcp) reconstruction plate and seven (7) cortex screws on (b)(6) 2017.Patient was returned to surgery on (b)(6) 2017 due to non-union and a bent plate.The bent plate was removed and replaced with another plate.Surgery was completed successfully with no delay.Patient reported as stable.Concomitant devices reported: cortex screw (part number unknown, lot number unknown, quantity 7).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Part 245.071, lot 8299772: manufacturing location: (b)(4).Release to warehouse date: march 01, 2013.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product 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 RECONSTRUCTION PLATE 7 HOLES/98MM
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7201100
• Report Number: 2939274-2018-50297
• Device Sequence Number: 11081954
• Product Code: KTT
• UDI-Device Identifier: 10886982169600
• UDI-Public: (01)10886982169600(10)8299772
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K000684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 245.071
• Device Catalogue Number: 245.071
• Device Lot Number: 8299772
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/22/2017
• Supplement Date Received by Manufacturer: 02/16/2018
• Initial Report FDA Received Date: 01/17/2018
• Supplement Report FDA Received Date: 02/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1