MAUDE Adverse Event Report: SYNTHES ELMIRA 3.5MM LCP SUPERIOR CLAVICLE PLATE/7 HOLE/RIGHT/100MM; PLATE,FIXATION,BONE

Model Number	02.112.082
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); 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 age & weight not available for reporting.Original implant date is unknown.Device is not expected to be returned for manufacturer review/investigation.Unknown therapy date.The 510k: additional 510k - k111540.(b)(4).No dhr review can be completed since the lot number provided is inaccurate or incomplete.The lot number provided is "8266962".Dhr requested.Product was not returned and lot number provided is incorrect.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.(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 on (b)(6) 2017 a revision surgery was performed for a broken 3.5 mm lcp superior clavicle plate/7 hole/right/100 mm due to non-union.The patient was experiencing pain in right clavicle and it was discovered that the implanted clavicle plate was broken.The revision surgery was completed successfully, there were no surgical delays, no fragments were generated from broken device, no additional x-rays taken and no other medical intervention required.A new depuy synthes clavicle plate was implanted into the patient and the patient status was reported as stable.Concomitant part: screws (part number unknown, lot number unknown, quantity seven).This report is 1 of 1 for com-(b)(4).

• Brand Name: 3.5MM LCP SUPERIOR CLAVICLE PLATE/7 HOLE/RIGHT/100MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6795833
• Report Number: 3003506883-2017-10162
• Device Sequence Number: 11012859
• Product Code: HRS
• UDI-Device Identifier: 10886982033130
• UDI-Public: (01)10886982033130(10)8266962
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K111540
• 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): 07/21/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.112.082
• Device Catalogue Number: 02.112.082
• Device Lot Number: 8266962
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2017
• Initial Report FDA Received Date: 08/15/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention