MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH IMPLANT INSERTER; MISC ORTHO SURGICAL INSTRUMENT

Model Number	03.820.129
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2019
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.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history record 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
It was reported that on an unknown date, during an unknown procedure, the implant inserter suffered a broken tip.The tip was recovered from the patient.It was unknown if there was a surgical delay.Patient outcome was unknown.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).
Event or Problem Description
It was noted the procedure was a c6-7 artificial disc replacement (adr) procedure.The prodisc implant was already implanted when the inserter tip broke off.The tip was recovered from the patient.No other implant was used.The procedure was successfully completed.There was no surgical delay.Patient outcome was good.Concomitant device: prodisc-c implant (part 09.820.065s, lot h505743, quantity 1).
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.Lot t922779: manufacturing site: tuttlingen.Release to warehouse date: july 17, 2008.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.A service and repair evaluation was completed: the device was initially received at the service and repair department.The customer reported that the implant inserter suffered a broken tip.The repair technician reported that the tip is broken, and parts are missing.Tip broken is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item was forwarded to customer quality.The evaluation was confirmed.A product investigation was completed: the implant inserter was received with one of the inserter tips broken off.The broken off inserter tip was not returned and is missing.All other subcomponents/assemblies were intact and present on the instrument.No other issues were identified with the returned components of the device.Dimensional inspection of the relevant feature (broken tip) could not be conducted due to post manufacturing damage.The relevant drawings reflecting the current and manufactured revision, were reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The complaint condition is confirmed as one of the inserter tips broken off.The broken off inserter tip was not returned and is missing.While no definitive root cause could be determined, it is possible that the condition was due to unintended forces and/or consistent use over the part¿s lifetime (10+ years).During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: IMPLANT INSERTER
• Common Device Name: MISC ORTHO SURGICAL INSTRUMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8672521
• Report Number: 8030965-2019-64951
• Device Sequence Number: 19365722
• Product Code: LXH
• UDI-Device Identifier: 10705034731681
• UDI-Public: (01)10705034731681
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,literatur
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2019

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 Model Number: 03.820.129
• Device Catalogue Number: 03.820.129
• Device Lot Number: T922779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 06/05/2019
• Supplement Report FDA Received Date: 06/28/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PRODISC-C IMPLANT EXTRA LARGE 5MM-STERILE
• Patient Age: 49 YR