MAUDE Adverse Event Report: SYNTHES ELMIRA 4.5MM TI NARROW LCP® PLATE 10 HOLES/188MM; PLATE,FIXATION,BONE

Model Number	224.601
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.: patient weight not provided for reporting.The plate was originally implanted three months ago.Device is not expected to be returned for manufacturer review/investigation.(b)(4).A device history record (dhr) review was performed product manufacture date: 03-apr-2009.Product manufacture location: synthes elmira.A review of the device history record (dhr) revealed no complaint related anomalies.The (dhr) shows this lot of 4.5mm narrow lcp plate 10 holes/188mm (part number 224.601, lot number 6112355) 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.Investigation summary: part # 224.601 / lot # 6112355 - product was not returned.The device history review revealed no complaint related anomalies.The (dhr) shows this lot of 4.5mm narrow lcp plate 10 holes/188mm (part number 224.601, lot number 6112355) 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.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 patient underwent revision of a plate on (b)(6) 2017 due to nonunion.The plate was originally implanted three months ago.All of the hardware was removed and replaced with new devices.The surgery was successfully completed with no surgical delay.This report is 1 of 2 for (b)(4).

• Brand Name: 4.5MM TI NARROW LCP® PLATE 10 HOLES/188MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6899187
• Report Number: 3003506883-2017-10219
• Device Sequence Number: 10942159
• Product Code: HRS
• UDI-Device Identifier: 10886982158543
• UDI-Public: (01)10886982158543(10)6112355
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K000682
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: 224.601
• Device Catalogue Number: 224.601
• Device Lot Number: 6112355
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 09/27/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 21 YR