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 Consequences Or Impact To Patient (2199)
Date of Event	09/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is synthes sales representative the investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records 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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, the tips of the cerclage passer forceps did not align when they were placed in the closed position.Also, this occurred with the first time use of the forceps.Patient and procedure involvement are unknown.This report is for one (1) cerclage passer, dividable forceps, large.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.Part: 03.221.011; lot: l735523; manufacturing site: umkirch; release to warehouse date: may 02, 2018.The device history record shows this lot 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.Investigation site: (b)(4); selected flow: 3.Visual (appearance not as expected) visual inspection visual inspection confirmed that the tips of the cerclage passer do not align when in closed position, furthermore one tube presents a dent on the tube edge.Dimensional inspection: the relevant dimensions of the tube could not be checked due to the damage incurred.However, dimensional inspection and functional test were performed per 100% at the time of manufacturing with no non-conformities documented.Document/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 one of the tubes is deformed, presenting a dent 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 may 2018 according to the specifications with a lot size of twenty-five ((b)(4)) pieces.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.The hardness parameters met specifications as well.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.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: 7923520
• Report Number: 8030965-2018-56871
• Device Sequence Number: 1624808
• Product Code: LXH
• UDI-Device Identifier: 07611819880108
• UDI-Public: (01)07611819880108
• Combination Product (Y/N): N
• Initial Reporter Country: LU
• 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): 09/04/2018

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: L735523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 09/28/2018; 11/13/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 10/03/2018; 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1