MAUDE Adverse Event Report: SYNTHES ELMIRA 3.5MM LCP PLATE 8 HOLES 111MM; PLATE,FIXATION,BONE

Catalog Number	223.581
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight reported as (b)(6) kg.Date of non-union is not known.Additional product codes: hwc, ktt.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history record (dhr) revealed no complaint related anomalies.The (dhr) shows this lot of 3.5mm lcp plate 8 holes 111mm (part number 223.581, lot number 7725205) 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.Product manufacture date: 24-jun-2014 product manufacture location: (b)(6).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 patient was involved in a motor vehicle accident on (b)(6) 2016.Initial treatments included multiple external fixation (ex-fix) at multiple anatomic sites, as well as traumatic amputation of the lower left leg.During the following weeks patient was returned for several surgeries with multiple surgeons to treat fractures of the left femur, right tibia, forearm, hand, and bi-lateral humeri.The right humerus was originally treated on (b)(6) 2016 and was later revised on (b)(6) 2016 due to non-union.This revision is addressed in (b)(4).Patient was again returned to surgery on (b)(6) 2017 due to hyper-trophic non-union of the same right humerus fracture.During revision procedure, surgeon removed one (1) 3.5mm locking compression plate (lcp) plate, one (1) 4.5mm narrow lcp plate, four (4) small fragment screws, and four (4) large fragment screws.All hardware was removed intact.Patient was revised to a temporary device and an antibiotic cement spacer to initiate the masquelet technique.The presence of infection has not been determined or ruled out.Patient will require at least one additional surgery for this fracture.Bone grafting and definitive fracture fixation will occur in approximately six (6) weeks.This report is for one (1) 3.5mm lcp plate.This is report 2 of 4 for (b)(4).

• Brand Name: 3.5MM LCP PLATE 8 HOLES 111MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6660062
• Report Number: 3003506883-2017-10118
• Device Sequence Number: 11123970
• Product Code: HRS
• UDI-Device Identifier: 10886982157959
• UDI-Public: (01)10886982157959(10)7725205
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2017

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: 223.581
• Device Lot Number: 7725205
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2017
• Initial Report FDA Received Date: 06/22/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 55