MAUDE Adverse Event Report: SYNTHES ELMIRA 3.5MM LCP PLATE 10 HOLES 137MM; PLATE, FIXATION, BONE

Catalog Number	223.601
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 was used for treatment, not diagnosis.Additional device product codes are hwc and ktt.Date of implant is unknown and was reported as approximately eight (8) weeks prior to (b)(6) 2017.The subject device is not expected to be returned to the synthes manufacturer for evaluation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record (dhr) review was performed for the complaint device lot.Manufacturing location: (b)(4).Manufacturing date: sep 24, 2012.The review of the device history record (dhr) revealed no complaint related anomalies.The (dhr) shows this lot of 3.5mm lcp plate 10 holes 137mm (part number 223.601, lot number 7038344) 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.(b)(4).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 revision surgery was performed on (b)(6) 2017 due to nonunion.The patient initially underwent an open reduction internal fixation (orif) of mid-shaft ulna approximately eight (8) weeks prior to the date of this report (exact date is unknown) to repair three butterfly bone fragments.It is unknown how the patient sustained the fractures.The patient was implanted with one (1) 3.5mm locking compression plate (lcp), seven (7) unknown 3.5mm cortex screws, and two (2) unknown 3.5mm locking screws.X-rays taken on unknown date for an unknown reason revealed the nonunion.Two (2) of the three (3) butterfly bone fragments healed and one (1) did not.It is unknown if the patient reported any symptoms.The patient underwent revision surgery on (b)(6) 2017.All hardware was removed intact.There were no issues with the hardware.The patient was revised to bone graft, one (1) 3.5mm lcp plate, and seven (7) screws.The revision surgery was successfully completed without delay or need for additional medical intervention.The patient¿s postsurgical status/outcome was reported as stable.This report is 1 of 3 for (b)(4).

• Brand Name: 3.5MM LCP PLATE 10 HOLES 137MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6379567
• Report Number: 3003506883-2017-10030
• Device Sequence Number: 779861
• Product Code: HRS
• UDI-Device Identifier: 10886982157997
• UDI-Public: (01)10886982157997(10)7038344
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 02/07/2017

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 Catalogue Number: 223.601
• Device Lot Number: 7038344
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2017
• Initial Report FDA Received Date: 03/05/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention