MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 12.5MM REAMER COMPONENT OF THE 03.168.004; INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH

Catalog Number	03.168.006
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	07/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The reported event required medical/surgical intervention to preclude permanent damage to a body structure and bone injury.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the osteosynthesis surgery for the femoral neck fracture (garden type) was performed with fns.During the surgery, the nut got loosened and the reamer protruded from the femoral head.The fns devices were implanted as planned.There was no surgical delay.The surgeon was worried the implant may penetrate the femoral head because there is no bone which support the implant from the femoral head side.The surgeon also commented that the rotation direction to loosen the nut and that of the reamer should be different.The alert date is (b)(6) 2019 (jst).No further information is available.Concomitant devices reported: unknown fns plate (part# unknown, lot# unknown, quantity# 1); unknown fns bolt (part# unknown, lot# unknown, quantity# 1); unknown antirotation screw (part# unknown, lot# unknown, quantity# 1) ; unknown locking screw (part# unknown, lot# unknown, quantity# 1).This complaint involves three (3) devices.This report is 3 of 3 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.

• Brand Name: 12.5MM REAMER COMPONENT OF THE 03.168.004
• Common Device Name: INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8839639
• Report Number: 8030965-2019-66647
• Device Sequence Number: 19518528
• Product Code: HWE
• UDI-Device Identifier: 07611819657328
• UDI-Public: (01)07611819657328
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2019

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 Catalogue Number: 03.168.006
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 09/13/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION; UNK - NAIL HEAD ELEMENTS: FNS BOLT; UNK - PLATES: FNS; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR