MAUDE Adverse Event Report: SYNTHES ELMIRA 2.7MM/3.5MM VA-LCP LAT ANT CLAVICLE PLATE/7 HOLE/77MM; PLATE,FIXATION,BONE

Model Number	02.112.045
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 not available for reporting.Additional product code: hwc.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 records (dhr) for lot 7534758, part number 02.112.045 (description: 2.7 mm/3.5 mm va-lcp lat ant clavicle plate/ 7 hole/ 77 mm), work order (b)(4) revealed zero documentation or manufacturing/processing characteristics that would have contributed to this complaint condition.All documentation was correct and complete at the time of release.All product specifications were met per the associated dhr at the time of release.A review of the device history records (dhr) for synthes lot 7489578, part number 19036 (description: 316l**pi02.112.045) revealed zero documentation or processing characteristics that would have contributed to this complaint condition.All documentation was correct and complete at the time of release.All product specifications were met per the associated dhr at the time of release.Place of manufacture: synthes (b)(4).Date of manufacture: 19 november 2013 (release to warehouse).Expiration date: n/a (non-sterile).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 the patient underwent revision surgery on (b)(6) 2017 to remove hardware due to a non-union of the clavicle.During the revision one (1) 2.7 mm/3.5 mm variable angle-locking compression plate (va-lcp) clavicle plate (7 hole), two (2) unknown lag screws, and five (5) unknown screws were removed whole and intact.The patient was implanted with a 3.5 mm lcp clavicle plate (7-hole) and six (6) unknown screws.The original surgery was performed on (b)(6) 2017 to treat a clavicle fracture.Post-operatively the patient was diagnosed with a non-union.It is unknown how the non-union was diagnosed or whether the patient had symptoms related to the event.The revision surgery was successfully completed with no surgical delay and no patient harm reported.Patient outcome was reported as good.This report is for one (1) 2.7 mm/3.5 mm va lcp clavicle plate.This is report 1 of 3 for (b)(4).

• Brand Name: 2.7MM/3.5MM VA-LCP LAT ANT CLAVICLE PLATE/7 HOLE/77MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6817644
• Report Number: 3003506883-2017-10182
• Device Sequence Number: 1569073
• Product Code: HRS
• UDI-Device Identifier: 10886982032997
• UDI-Public: (01)10886982032997(10)7534758
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/04/2017

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: 02.112.045
• Device Catalogue Number: 02.112.045
• Device Lot Number: 7534758
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2017
• Initial Report FDA Received Date: 08/24/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention