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

Catalog Number	03.010.065
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	08/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review / investigation.(b)(4).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 left hindfoot arthrodesis with nail procedure on (b)(6) 2019, the aiming arm assembly misaligned both proximal screws.The surgeon inserted a left expert hindfoot nail.It was confirmed the nail was loaded properly onto insertion handle by confirming the bend of the nail matched the etched picture on the insertion handle.The surgeon also tested the aiming arm before insertion into patient by putting the triple trocar assembly and corresponding drill bit through the corresponding nail holes.With the nail inserted and the aiming arm in (p) position, the surgeon inserted two (2) 6.0 mm screws into the calcaneus without issue.He also drilled and inserted the oblique 5.0 mm screw into the talus without issue.When the surgeon tried to drill through the (two) 2 (correct) proximal holes labelled (static) and (180) the 4.2 mm drill bit encountered the nail itself and could not pass through the designated nail holes.For these proximal screws the aiming arm showed (m) in the window as appropriate and he used triple trocar assembly with drill bit, which were the same items he had used for the talar screw.With no success drilling the proximal screws through the aiming arm the surgeon had to remove the aiming arm and free-hand the two (2) proximal screws.This added 10 minutes to the procedure.Procedure completed successfully.Concomitant device reported: unknown screw (part # unknown, lot # unknown, quantity# unknown).This is report 6 of 9 for (b)(4).

• Brand Name: 8.0MM/4.2MM DRILL SLEEVE 200MM
• Common Device Name: GUIDE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9118785
• Report Number: 8030965-2019-68677
• Device Sequence Number: 11436136
• Product Code: FZX
• UDI-Device Identifier: 07611819760929
• UDI-Public: (01)07611819760929
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 08/30/2019

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: 03.010.065
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 09/25/2019
• 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: 68 YR