MAUDE Adverse Event Report: SYNTHES ELMIRA LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 3 HOLES/33MM; PLATE,FIXATION,BONE

Model Number	241.331
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Impaired Healing (2378); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient height reporter was (b)(6).Additional patient id: (b)(6).Date of event is unknown.Date of implant is unknown date approximately 15 years prior to the date of revision on (b)(6) 2017.Device is not expected to be returned for manufacturer review/investigation.Device history records review was completed for part# 241.331, lot# 7827331.Manufacturing location: (b)(6), manufacturing date: oct 22, 2014.A review of the device history record (dhr) revealed no complaint related anomalies.The (dhr) shows this lot of lcp one-third tubular plate with collar 3 holes/33mm (part number 241.331, lot number 7827331) 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.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 patient underwent revision of a left side ankle fusion on (b)(6) 2017 due to malunion.Two plates and six screws were originally implanted approximately 15 years ago.The fusion healed in mal-reduction.The plate and screws were removed intact, an osteotomy performed, the deformity corrected, and the ankle refused.Two new plates and cortex screws were implanted.The surgery was successfully completed with no delay.The patient outcome was reported as fine.This report is for one (1) lcp one-third tubular plate with collar 3 holes.This is report 1 of 8 for (b)(4).

• Brand Name: LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 3 HOLES/33MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6973985
• Report Number: 3003506883-2017-10245
• Device Sequence Number: 498319
• Product Code: HRS
• UDI-Device Identifier: 10886982166814
• UDI-Public: (01)10886982166814(10)7827331
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K011335
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/08/2017

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: Physician
• Device Model Number: 241.331
• Device Catalogue Number: 241.331
• Device Lot Number: 7827331
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2017
• Initial Report FDA Received Date: 10/24/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 67