MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH REAMER CPL; INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH

Catalog Number 03.168.004

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Patient identifier and weight not available for reporting.Patient age reported as between 50 and 69 years.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 Description

Device report from synthes europe reports an event in the (b)(6) as follows: it was reported patient underwent a procedure on unknown date to repair a transcervical gaden iii pauwels ii fracture of the right femoral neck using the femoral neck system (fns).During the procedure, while drilling for the implant, the fixation sleeve (drill stop) loosened due to soft tissue influence.As a result, the drilling was too deep.Surgery was completed successfully with no reported patient harm.Concomitant devices reported: bolt for fns 100mm (04.168.300s, lot number unknown, quantity 1), antirotation screw for fns 100mm (04.168.500s, lot number unknown, quantity 1), fns plate 1 hole (04.168.000s, lot number unknown, quantity 1), 10.2mm cannulated drill bit 251mm (03.168.005, lot number unknown, quantity 1), 12.5 remer (03.168.006, lot number unknown, quantity 1), nut for reamer (03.168.007, lot number unknown, quantity 1).This report is for one (1) complete opening drill bit/reamer assembly.This is report 1 of 1 for (b)(4).

• Brand Name: REAMER CPL
• Type of Device: INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7623395
• MDR Text Key: 111836299
• Report Number: 8030965-2018-54472
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819657304
• UDI-Public: (01)07611819657304
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.168.004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention