MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CERCLAGE PASSER, DIVIDABLE FORCEPS, LARGE; MISC ORTHO SURGICAL INSTR

Catalog Number	03.221.011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: there was no known reported patient involvement associated with the complained event.Device is an instrument and is not implanted/explanted.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.A review of the device history records has been requested and is currently pending completion.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 pre-operatively the cerclage passer broke.No patient involvement.Upon receipt of the complained instrument at manufacturer¿s analysis site, it could be confirmed that the tip of the cerclage passer is not broken off as previously mentioned in the device report but one of the tubes is deformed and presents scratches and dents; hence the instrument does not close properly.(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.H3, h4, h6: a device history record (dhr) review was conducted for part number: 03.221.011, synthes lot number: l310108: release to warehouse date: 26 may 2017, manufacturing site: umkirch: no non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.H3, h6: a product investigation was conducted.Visual inspection: visual inspection confirmed that the tip of the cerclage passer is not broken off as mentioned in the complaint description but one of the tubes is deformed and presents scratches and dents.Functional test / dimensional inspection: functional test failed due to the damage incurred; the deformation of the tube prevents the instrument from closing properly.However, dimensional inspection and functional test were performed per 100% at the time of manufacturing with no non-conformities documented.Drawing/specification review: the investigation confirmed that the damage of the tube is determined to be post-production/acceptance criteria, therefore no drawing/specification review is needed.Summary: the complaint condition is confirmed as one of the tubes is deformed consequently the instrument does not close properly.The review of the production history revealed that this instrument was manufactured in may 2017 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.No manufacturing related issues that would have contributed to this complaint were found.Furthermore, these instruments are function checked per 100% before they leave the manufacturing site.Based on these findings we have to assume that too much force was applied while inserting the cerclage passer, which finally caused the deformation of the tube.In this regard we would like to point out that further information / precaution hints can be found in the respective surgical technique (036.000.769).During the investigation, no product design or manufacturing issues were identified that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: CERCLAGE PASSER, DIVIDABLE FORCEPS, LARGE
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7485191
• Report Number: 8030965-2018-53525
• Device Sequence Number: 1592046
• Product Code: LXH
• UDI-Device Identifier: 07611819880108
• UDI-Public: (01)07611819880108
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.221.011
• Device Lot Number: L310108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 06/19/2018
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 06/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1