MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 3.5MM LCP RECONSTRUCTION PLATE 12 HOLES/168MM; APPLIANCE, FIXATION, NAIL

Model Number	245.121
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 a hardware removal was performed on (b)(6) 2017 due to a broken 12 hole 3.5mm locking compression (lcp) reconstruction plate.The plate was discovered to have been broken through an x-ray taken on an unknown date.The date of the original clavicle open reduction internal fixation (orif) was (b)(6) 2017.The plate was removed with no delay in surgery or reported harm to the patient.This is report 1 of 1 for (b)(4).

• Brand Name: 3.5MM LCP RECONSTRUCTION PLATE 12 HOLES/168MM
• 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: 7205863
• Report Number: 2939274-2018-50321
• Device Sequence Number: 13682390
• Product Code: KTT
• UDI-Device Identifier: 10886982169686
• UDI-Public: (01)10886982169686(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 12/21/2017

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: 245.121
• Device Catalogue Number: 245.121
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/21/2017
• Initial Report FDA Received Date: 01/19/2018
• 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
• Patient Age: 16 YR