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	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: it is unknown when device became deformed.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review has been requested.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 during an unknown procedure on (b)(6) 2018, the cerclage passer was found to be deformed.The instrument cannot close properly.Surgical outcome and patient status is unknown.This report is for a cerclage passer, dividable forceps, large.(b)(4).
Additional Manufacturer Narrative
The device has been 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.
Event or Problem Description
There was no patient harm reported.
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.A device history record (dhr) review was conducted: part: 03.221.011; lot: 9798579: manufacturing site: umkirch, release to warehouse date: 05.April 2016: the device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.A product investigation was conducted.Visual inspection: visual inspection confirmed that the tips of the cerclage passer do not align when in closed position, furthermore both tubes present deformations and one tube shows dents on the tube edge.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 criterias, therefore no drawing/specification review is needed.Summary: the complaint condition is confirmed as the tubes are deformed presenting nicks and dents on the edge of the tube consequently the instrument does not close properly.The review of the production history revealed that this instrument was manufactured in april 2016 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 tubes.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: 7837141
• Report Number: 8030965-2018-56104
• Device Sequence Number: 19126472
• Product Code: LXH
• UDI-Device Identifier: 07611819880108
• UDI-Public: (01)07611819880108
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/15/2018

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: 9798579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 10/08/2018; 11/05/2018
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 10/17/2018; 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1