MAUDE Adverse Event Report: SYNTHES ELMIRA 4.5MM LCP® CONDYLAR PLATE 6 HOLES/170MM-RIGHT; PLATE, FIXATION, BONE

Catalog Number	222.656
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of device breakage is not known.Additional product codes: hty, jdw, hwc.Date of implant reported only as (b)(6) 2016.Concomitant device therapy date reported only as (b)(6) 2016.(b)(6).A review of the device history records has been requested.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it is reported patient underwent an open reduction internal fixation (orif) procedure for a distal femur fracture in (b)(6) 2016.On unknown date it was revealed the plate was broken.Patient was returned to surgery on (b)(6) 2017 where surgeon removed the broken 4.5mm locking compression plate (lcp) condylar plate and screws, reduced the fracture, and revised the patient to a longer plate.Surgery was completed with a delay of approximately 5 minutes.Concomitant devices reported: screws (part number unknown, lot number unknown, quantity unknown).This report is for one (1) 4.5mm lcp condylar plate.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device history records review was conducted.Part mfg date: 08sep2016.Part exp.Date: n/a (for s part numbers) manufacturing location: (b)(4).Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 4.5mm condylar 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.Raw material used for 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.A manufacturing investigation action was conducted/performed.(b)(6) reported that in (b)(6) 2016 an open reduction internal fixation had been performed, but on (b)(6) 2017 a revision surgery was performed for a broken 4.5mm lcp condylar plate.The broken plate and screws were removed and the fracture was reduced and fixed with a longer plate.A five minute surgical delay was reported and no reported patient harm.Concomitant devices reported: screws (part number unknown, lot number unknown, quantity 7) the patient reported with pain on an unknown date.X-rays were done and it was discovered that the plate had broken.One cannulated screw head was also broken prior to the revision surgery.All fragments were removed at time of revision.The original fracture was proximal to a knee implant.The knee implant was not a depuy implant and there were no other synthes devices implanted around the fracture.Customer quality (cq) engineering investigation: one broken plate was received in 2 pieces and the distal portion of a broken screw was received at cq.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the 2 returned complaint devices broke postoperatively.The following were returned as concomitant devices without an alleged complaint condition.Part #: unk screw -locking, lot #: unk, quantity: 1; part #: unk screw - cortex, lot #: unk, quantity: 1; part #: unk screw - locking cannulated, lot #: unk, quantity: 5.Upon visual inspection there is no evidence that these devices contributed to the complaint condition, and therefore no additional investigation will be performed on these devices.A visual inspection under 5x magnification, dimensional inspection of feature(s) related to this complaint, device history record (dhr) review, complaint history review, drawing review, and risk assessment review were performed for the 2 complaint devices as part of this investigation.The report indicates that: no product design issues or discrepancies were observed.Device 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
Update 05-0517: the patient reported with pain on an unknown date.X-rays were done and it was discovered that the plate had broken.One cannulated screw head was also broken prior to the revision surgery.All fragments were removed at time of revision.The original fracture was proximal to a knee implant.The knee implant was not a depuy implant and there were no other synthes devices implanted around the fracture.There are 2 device in this complaint this report is 1 of 2 for (b)(4).

• Brand Name: 4.5MM LCP® CONDYLAR PLATE 6 HOLES/170MM-RIGHT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6531927
• Report Number: 3003506883-2017-10067
• Device Sequence Number: 1374169
• Product Code: HRS
• UDI-Device Identifier: 10886982157287
• UDI-Public: (01)10886982157287(10)H179656
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K000066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2017

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: 222.656
• Device Lot Number: H179656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/05/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2017
• Supplement Report FDA Received Date: 05/18/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCREW (PART AND LOT UNKNOWN, QTY UNKNOWN)
• Outcome Attributed to Adverse Event: Required Intervention