MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 8.0MM/4.2MM DRILL SLEEVE 200MM; GUIDE, SURGICAL, INSTRUMENT

Model Number	03.010.065
Medical Device Problem Codes	Device-Device Incompatibility (2919); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	06/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is company representative.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.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.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 during a femoral nailing procedure on (b)(6) 2020 a device misalignment occurred while implanting the nail.At the time of locking with the reconstruction technique, the guide wire went outside the femoral head.The nail was slightly displaced and the reference protection sleeves were placed again with the reference drill guide to perform the insertion of the guide wire.The wire collided with the nail and alignment did not occur, so the surgeon performed a maneuver with a tissue protection sleeve so that the guide wire could be placed in the femoral head.It was further reported the flexible shaft of synream tip was damaged and does not grip the milling heads well.Surgical delay and patient status are unknown.Concomitant device reported: unk -guides/sleeves/aiming: aiming arm (part# unknown, lot# unknown, quantity# 1).Unknown reamer head (part# unknown, lot# unknown, quantity# 1).This is report 4 of 5 for (b)(4).
Event or Problem Description
The initial complaint was reviewed and found to be a duplicate of complaint (b)(4).This device has already been captured on manufacturer report number 8030965-2020-04491.
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.H11: b1, b5, h1, h6: the initial complaint was reviewed and found to be a duplicate of complaint (b)(4).This device has already been captured on manufacturer report number 8030965-2020-04491.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: 8.0MM/4.2MM DRILL SLEEVE 200MM
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10200389
• Report Number: 8030965-2020-04471
• Device Sequence Number: 2526278
• Product Code: FZX
• UDI-Device Identifier: 10886982067395
• UDI-Public: (01)10886982067395
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2020

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: 03.010.065
• Device Catalogue Number: 03.010.065
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 08/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE Ø3.2 L400; PROTECT SLEEVE 12/8 L188; SYNREAM FLEXSHAFT; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM; UNK - NAILS; UNK - REAMERS: REAMER HEAD
• Outcome Attributed to Adverse Event: Required Intervention