MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SPINDLE FOR EVOLUTION; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.825.002
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received.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 an unknown date, during an incoming inspection of a loaner set, the spindle was discovered as broken.No information about the event or patient involvement.This report is for one (1) spindle for evolution this is report 1 of 1 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.Visual inspection: upon visual inspection, the knob was received separated from the spindle.It was observed that the weld around the knob was cracked around the entire circumference.The surface of the instrument shows visible signs of wear on the whole instrument.Dimensional inspection: since the complaint condition involved a cracked weld, a relevant dimensional check could not be performed.Document/specification review: review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Conclusion: previous investigations on the complaint condition determined that the weld was not strong enough to withstand the applied impaction load from normal use.A dco was placed on 11-may-17, to update the spindle drawing and to change the weld specification from lbw 0.2 to gtaw 0.45 with filler to enhance durability.Therefore, during the investigation no unidentified product design issues or discrepancies were observed that may have contributed to the complaint condition.While no definitive root cause could be determined it is possible that the complaint condition is the result of force applied on the device resulting in stresses beyond the failure limit during usage.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history : part #: 03.825.002, synthes lot number: h263971 , supplier lot number: h263971, manufacturing site: synthes monument, release to warehouse date: 10-may-2017, supplier: (b)(4).The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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.H10: additional narrative: d10, e1, h3, h6: 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.

• Brand Name: SPINDLE FOR EVOLUTION
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9727623
• Report Number: 8030965-2020-01235
• Device Sequence Number: 19451552
• Product Code: LXH
• UDI-Device Identifier: 07611819542303
• UDI-Public: (01)07611819542303
• 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): 01/27/2020

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: 03.825.002
• Device Lot Number: H263971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 02/19/2020; 03/24/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 03/17/2020; 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1