MAUDE Adverse Event Report: SYNTHES ELMIRA 4.5MM LCP® MEDIAL PROXIMAL TIBIA PLATE 16H/LEFT 322MM; PLATE, FIXATION, BONE

Catalog Number	239.997
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.(therapy date): exact date of implant is unknown but was reported as approximately three (3) months prior to (b)(6) 2016.He subject device is not expected to be returned to the synthes manufacturer for evaluation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review was performed for the subject device lot.Manufacturer: synthes elmira.Date of manufacture: apr 10, 2006.The review showed that there were no complaint related anomalies.The device history record shows this lot of 4.5 mm medial proximal 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.(b)(4).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 took place on (b)(6) 2016 for a broken 4.5 mm locking compression plate (lcp) medial proximal tibia plate.It was reported that the patient was originally implanted approximately three (3) months prior to (b)(6) 2016 (exact date unknown) with plate and an unknown quantity of unknown screws.It was reported that the patient was non-compliant; walking and bearing weight on the operated leg.The plate broke at one screw hole and the other side of the plate was bent.The patient was revised to a tibia nail.All other implants were removed intact.There was no harm to patient during the revision surgery or surgical delay.Concomitant devices reported: screw.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
(b)(6).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
Customer quality unit received a maude report forwarded from department of human services; this report is against user facility # (b)(4).Only additional and/or corrected information will be contained in this report.A copy of the maude event report is attached.

• Brand Name: 4.5MM LCP® MEDIAL PROXIMAL TIBIA PLATE 16H/LEFT 322MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6266671
• Report Number: 3003506883-2017-10008
• Device Sequence Number: 857869
• Product Code: HRS
• UDI-Device Identifier: 10886982164094
• UDI-Public: (01)10886982164094(10)5129295
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K050646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2016

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: 239.997
• Device Lot Number: 5129295
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2017
• Supplement Report FDA Received Date: 02/23/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SCREWS, QUANTITY UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 136