MAUDE Adverse Event Report: SYNTHES ELMIRA 4.5MM NARROW LCP® PLATE 9 HOLES/170MM; PLATE, FIXATION, BONE

Catalog Number	224.591
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
Device used for treatment, not diagnosis.Additional product codes: hwc, ktt.Device is not expected to be returned for manufacturer review/investigation.Concomitant medical products: large fragment cortex screw (various sizes) (part numbers: 214.8xx, lot number unknown, quantity 6).(b)(4): patient had a non-union and plate breakage requiring revision surgery device history records review was conducted.The report indicates that the part# 224.591 lot# h251366; part mfg.Date: 14dec2016; part exp.Date: n/a (for s part numbers); part mfg.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 narrow lcp 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.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 underwent revision surgery due to a nonunion and broken 4.5mm narrow locking compression plate (lcp) plate.Patient had the initial open reduction internal fixation (orif) procedure of the left femoral shaft on (b)(6) 2017 for a fracture.Patient was implanted with one 4.5mm narrow lcp plate and six large fragment cortex screws of various sizes.It is unknown how the broken plate and nonunion were discovered.It is unknown if patient reported any adverse event.It is unknown if there were any reported issues during initial surgery.Revision surgery was performed on (b)(6) 2017.The plate broke in two pieces.It was a clean break and no fragments were generated.The plate and screws were easily removed and did not require additional intervention.The screws were intact.Patient was revised to adolescent lateral entry femoral nail.Surgery was successfully completed without surgical delay.No other medical intervention required.Patient status/outcome was reported as stable.There is 1 device in this complaint concomitant medical products: large fragment cortex screw (various sizes) (part numbers: 214.8xx, lot number unknown, quantity 6).This report is 1 of 1 for (b)(4).

• Brand Name: 4.5MM NARROW LCP® PLATE 9 HOLES/170MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6524801
• Report Number: 3003506883-2017-10064
• Device Sequence Number: 16276313
• Product Code: HRS
• UDI-Device Identifier: 10886982158529
• UDI-Public: (01)10886982158529(10)H251366
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/03/2017

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: 224.591
• Device Lot Number: H251366
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2017
• Initial Report FDA Received Date: 04/26/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 14 YR
• Patient Weight: 50