MAUDE Adverse Event Report: SYNTHES ELMIRA 4.5MM NARROW LCP® PLATE 16 HOLES/296MM; PLATE,FIXATION,BONE

Model Number	224.661
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Additional product device codes: hwc, ktt.Complainant device is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was performed for part #: 224.661, lot #: 7410730: part mfg date: 17jun2013, part exp.Date: n/a (for s part numbers), manufacturing location: (b)(4).A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 4.5 mm 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.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 revision surgery was performed on (b)(6) 2017 due to broken plate and to treat tibia fracture.Initially the patient was implanted with one (1) plate and 12 (twelve) screws.The plate broke internally and patient presented with pain.The fracture did not heal as expected (non-union).Due to this reason, revision surgery was performed.All implants (1 plate and 12 screws) removed without any difficulty.Post-operative x-rays confirmed no fragments were retained.Revision surgery was completed successfully without any delay.The patient was revised to new synthes plate and also competitor¿s device (restoration hip, stryker).Patient is now reported to be in stable condition.Concomitant devices reported: cortex screw (part #: 214.836, qty: 2), cortex screws (part #: 214.850, qty: 2), cortex screws (part #: 214.838, qty: 6), cortex screw (part #: 214.840, qty: 1), cortex screw (part #: 214.834, qty: 1) this report is for one(1) 4.5 mm narrow lcp plate.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 4.5MM NARROW LCP® PLATE 16 HOLES/296MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6969799
• Report Number: 3003506883-2017-10243
• Device Sequence Number: 67506
• Product Code: HRS
• UDI-Device Identifier: 10886982158628
• UDI-Public: (01)10886982158628(10)7410730
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 10/03/2017

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 Model Number: 224.661
• Device Catalogue Number: 224.661
• Device Lot Number: 7410730
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2017
• Initial Report FDA Received Date: 10/23/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CORTEX SCREW (PART # 214.836, LOT # UNK, QTY 2); CORTEX SCREW (PART # 214.840, LOT # UNK, QTY 1); CORTEX SCREW (PART #: 214.834, LOT #: UNK, QTY: 1); CORTEX SCREWS (PART # 214.838, LOT # UNK, QTY 6); CORTEX SCREWS (PART # 214.850, LOT # UNK, QTY 2)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 81