MAUDE Adverse Event Report: SYNTHES ELMIRA 2.7/3.5MM VA-LCP ANTEROLATERALDISTAL TIBIA PL/6 HOLES/LEFT; PLATE, FIXATION, BONE

Catalog Number	02.118.205
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product code: hwc.A device history record (dhr) review was performed for part #02.118.205, lot #h129663: original part manufacturing location: (b)(4) manufacturing facility, original part manufacturing date: 24-june-2016, part exp.Date: n/a: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of va-lcp anterolateral distal tibia plates was processed through the normal manufacturing and inspection operations with no non-conformances or rework noted.This order met all dimensional and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications at time of acceptance.No nonconforming reports were noted.The raw material met all dimensional and visual criteria at the time of release with no issues documented.The device has been received and the product evaluation is in progress.No conclusion can be drawn.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 a left tibial revision surgery was performed on (b)(6) 2017 as the plate broke postoperatively in half at the fracture site due to a nonunion.No fragments were generated.No screws were impacted.The patient was revised with a medial distal tibial plate.There was no surgical delay and the procedure was completed successfully with no patient harm.Concomitant devices reported: screw (part # unknown, lot # unknown, quantity 1).This report is for one (1) 2.7/3.5mm va-lcp anterolateral distal tibia plate.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
A product development investigation was performed for the subject device (2.7/3.5mm va-lcp anterolateraldistal tibia pl/6 holes/left, part number 02.118.205, lot number h129663).The subject device was returned with the complaint condition stating: the 02.118.205, lot number h129663, 2.7/3.5mm va-lcp anterolateraldistal tibia pl/6 holes/left was returned in two pieces.The breakage point is at the distal most combi-hole, located approximately 33 mm from the distal end of the implant.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already broken.A visual inspection, device history record (dhr) review, drawing review, and dcrm review were performed as part of this investigation.The part #02.118.205 va lcp tibia plate is an implant intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia.The device was returned and it was reported that the plate was broken in half.This condition is confirmed; the device was received broken in two pieces, the breakage point is at the distal most combi-hole, located approximately 33 mm from the distal end of the implant.The balance of the returned device is in fairly worn condition, there are various scratches throughout the implant, and multiple holes on the implant are chipped, possibly due to rough handling during extraction.This part was manufactured 6/2016.The thickness of the plate at the line of breakage for both pieces were measured to be approximately 2.8 mm, which is within specification of 2.5mm-2.9mm per drawing.All measurements were taken with caliper.Although a definitive root cause could not be determined, this complaint condition is likely caused by a non-union at the hardware fracture site.When there is insufficient reduction or healing is delayed there are increased loads the implant must withstand, that would normally be supported by the bone, which could eventually cause it to break due to metal fatigue drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of va-lcp anterolateral distal tibia plates was processed through the normal manufacturing and inspection operations with no non-conformances or rework noted.This order met all dimensional and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications at time of acceptance.No nonconforming reports were noted.The raw material met all dimensional and visual criteria at the time of release with no issues documented.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.7/3.5MM VA-LCP ANTEROLATERALDISTAL TIBIA PL/6 HOLES/LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6604950
• Report Number: 3003506883-2017-10098
• Device Sequence Number: 789237
• Product Code: HRS
• UDI-Device Identifier: 10886982038364
• UDI-Public: (01)10886982038364(10)H129663
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K121601
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2017

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: 02.118.205
• Device Lot Number: H129663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/08/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2017
• Supplement Report FDA Received Date: 06/22/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR