MAUDE Adverse Event Report: SYNTHES ELMIRA 2.4MM LCP® STRAIGHT WRIST PLATE 170MM; PLATE,FIXATION,BONE

Catalog Number	SD242.003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Device is not expected to be returned for manufacturer review/investigation.(b)(4): it was reported that the patient experienced pain, and x-rays revealed a broken plate.This event required additional surgical intervention to remove the plate and conversion to a cast.Device history records review was conducted.The report indicates that: dhr review for: product manufacture date: 05-sep-2014.Product manufacture location: synthes (b)(4).A review of the device history record (dhr) revealed no complaint related anomalies.The (dhr) shows this lot of 2.4mm lcp straight wrist plate (part number sd242.003, lot number 7781820) 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 with no non-conformances or rework noted.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 is reported patient was implanted with a 2.4mm locking compression plate (lcp) straight wrist plate, five (5) 2.4mm locking screws, and four (4) 2.4mm cortex screws to repair a fracture of the left distal radius on (b)(6) 2016.This plate, known as a ¿bridge¿ plate, is typically removed after three (3) months.During routine examination on december 7, 2016, x-rays revealed patient was not completely healed but all hardware was intact.Patient later complained of pain and additional x-rays taken on (b)(6) 2016 revealed the plate had broken directly in the center of the plate.Patient was returned to surgery on (b)(6) 2016 where surgeon removed all hardware.All nine (9) screws were reported to be intact at the time of explant.Patient was not revised to additional hardware; surgeon will instead apply a cast.Surgeon reports patient is non-compliant and a smoker, contributing to the delay in healing.All hardware was removed easily and surgery was completed successfully with no delay and no harm to patient.Concomitant medical products reported: 2.4mm locking screw (part number unknown, lot number unknown, quantity 5), 2.4mm cortex screw (part number unknown, lot number unknown, quantity 4).This report is 1 of 1 for (b)(4).

• Brand Name: 2.4MM LCP® STRAIGHT WRIST PLATE 170MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6227170
• Report Number: 3003506883-2017-10002
• Device Sequence Number: 16158373
• Product Code: HRS
• UDI-Device Identifier: 10886982003638
• UDI-Public: (01)10886982003638(10)7781820
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K040588
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/14/2016

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: SD242.003
• Device Lot Number: 7781820
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2016
• Initial Report FDA Received Date: 01/05/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.4MM CORTEX SCREW PART & LOT # UNK QTY 4; 2.4MM LOCKING SCREW PART & LOT # UNK QTY 5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Weight: 77