MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH DCS 95° 10HO L178 SST; PLATE, FIXATION, BONE

Model Number	281.900
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Date of birth and weight not available for reporting.Event: unknown date in 2017.Unknown implant date in (b)(6) 2017.Device is not expected to return for investigation.Device history record review: part no.: 281.900.Lot no.: 9730141 manufacturing location: (b)(4).Release to warehouse date: dec.23, 2015.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition the investigation could not be completed; no conclusion could be drawn, as no product was received.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
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that on an unknown date in (b)(6) 2017 a patient was implanted with a plate and screws from the dynamic condylar screw system (dcs) for a subtrochanteric fracture of the right femur.On an unknown date the plate was found to be broken in-situ, reportedly caused by fatigue of the implants.A revision surgery was performed on (b)(6) 2017.It was reported that the patient did not suffer from any falls during the post-op period.There was no report of surgical delay or patient harm.The surgery was completed successfully.Concomitant devices reported: screws (part # 280.65, lot# unknown, quantity 1), screws (part # 214.060, lot# unknown, quantity 1), screws (part # 214.040, lot# unknown, quantity 1), screws (part # 214.036, lot# unknown, quantity 1), screws (part # 214.032, lot# unknown, quantity 3), screws (part # 214.030, lot# unknown, quantity 1).(b)(4).

• Brand Name: DCS 95° 10HO L178 SST
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7207255
• Report Number: 8030965-2018-50504
• Device Sequence Number: 13634067
• Product Code: HRS
• UDI-Device Identifier: 10886982177988
• UDI-Public: (01)10886982177988(10)9730141
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K791619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/28/2017

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: 281.900
• Device Catalogue Number: 281.900
• Device Lot Number: 9730141
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/28/2017
• Initial Report FDA Received Date: 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR