MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CANN CONNECTING SCR W/INTERNL THRD F/PERCUTAN INSERTN HANDLE; GUIDE

Catalog Number	03.010.146
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).The investigation could not be completed; no conclusion could be drawn, as no product was received.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 4 of 9 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: the device was received, the investigation is in progress, 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.
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.Investigation site: cq zuchwil selected flow: device interaction.Visual inspection: the visual inspection has shown that returned cannulated connecting screw shows wear marks and scratches on the surface of the whole part.Also the threaded part section is worn and indicate some damages on thread flank.The part is all in all in used condition.Functional test: a functional check was performed with available parts (nail, protection sleeve, drill sleeve, drill bit and trocar).Due to strongly damaged pins at the insertion handle a certain force had to be applied to attach the nail to the insertion handle.Afterwards it was found that the drill pass without any problems into designated nail holes.Therefore the reported malfunction was not able to be reproduced during the functional test and therefore the complaint is unconfirmed.As no product failure was identified and the complained malfunction was not able to be replicate during the performed cq evaluation the in the investigation flow listed remaining investigation steps are not required.Summary: the visual inspection has shown that returned cannulated connecting screw shows wear marks and scratches on the surface of the whole part.Also the threaded part section is worn and indicate some damages on thread flank.The part is all in all in used condition.This lot was manufactured in january 2013 according to the specification.There were no issues during the manufacturing of the product that would contribute to this complaint condition.Unfortunately, we are not able to determine the exact cause which has let to this complaint.A functional check was performed with available parts and it was found that the drill bit pass without any problems into designated nail holes.As it was not possible to attach the nail into the insertion handle with certain force, we only can assume that possibly an insufficient connection between nail and insertion handle could have let to the reported problem based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.The complaint pictures are only attached on pi-(b)(4).Device history lot manufacturing location: orchid unique / inspection, packaging and release by: monument release to warehouse date(s): jan 31, 2013 quantity 47, 21-feb-2013 quantity 35, 21-mar-2013 quantity 15.Part number: 03.010.146, cann connecting scr w/internal thrd f/percutan insertn handle.Lot number: u162231 (non-sterile).Lot quantity: 97 (three batches total).Purchased finished goods travelers met all inspection acceptance criteria.Inspection sheets, incoming final inspection ns031116 rev b met all inspection acceptance criteria.Certificates of compliance received from orchid dated 10-dec-2012 were reviewed and determined to be conforming.Packaging label logs lppf, lmd/lpf rev a were reviewed and determined to be conforming.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection, packaging or release that would contribute to this complaint condition.Device history review sep 26, 2019: dhr reviewed.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.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: CANN CONNECTING SCR W/INTERNL THRD F/PERCUTAN INSERTN HANDLE
• Common Device Name: GUIDE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9118630
• Report Number: 8030965-2019-68674
• Device Sequence Number: 11243871
• Product Code: FZX
• UDI-Device Identifier: 07611819394445
• UDI-Public: (01)07611819394445
• 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,Followup,Followup
• 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: 03.010.146
• Device Lot Number: U162231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 10/01/2019; 10/31/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 10/15/2019; 11/18/2019
• 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: UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR