MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH COMPLETE OPENING DRILL BIT/REAMER ASSEMBLY; INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH

Catalog Number	03.168.004
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is unknown.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter phone number was not provided.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 or Problem Description
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the surgeon used the femoral neck system to fix a femoral neck fracture.The desired implant length was not available in the hospital, so he decided to use a longer implant.The operating room (or) nurse set up the reamer to drill for the chosen longer implant length and not for the originally shorter measured length.Reamer was stopped after having penetrated the hip joint.Concomitant device: femoral neck system (part 04.168.100s, lot unknown, quantity 1).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device 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
According to professor stoffel, the error occurred due to a miss-communication between him and his operating room-nurse and was not caused/initiated by the product.Therefore, he does not wish to report the case and disclose more information.

• Brand Name: COMPLETE OPENING DRILL BIT/REAMER ASSEMBLY
• 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: 7454469
• Report Number: 8030965-2018-53316
• Device Sequence Number: 11078751
• Product Code: HWE
• UDI-Device Identifier: 07611819657298
• UDI-Public: (01)07611819657298
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2018

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: 03.168.004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/07/2018
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 05/29/2018
• 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