MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SYNCAGE EVOLUTION SPINDLE; MISC. ORTHO SURGICAL INSTR.

Catalog Number	03.825.002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation flow: damage.Visual inspection: the syncage evolution spindle (part # 03.825.002 lot # h052900) was received at us cq.Upon magnification, the weld that joins the shaft and the knob has a hairline crack along the entire circumference of the weld.The knob can toggle slightly when applying rotational force, the shaft cannot be separated from the knob.There are surface scratches along the shaft of the device that are consistent with normal wear.The received condition is consistent with the complaint condition thus the complaint is confirmed device failure/defect identified? yes; weld failure.Dimensional inspection: shaft diameter just proximal to the weld was measured.Specified dimensions shaft diameter = 6.2mm +/- 0.05.Measured dimensions: shaft diameter = 6.20mm; conforming.Manufacturing record evaluation: the received syncage evolution spindle (part # 03.825.002, lot # h052900) was manufactured at avalign technologies ¿ (b)(4) on (b)(6) 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Conclusion: the complaint was confirmed for the received syncage evolution spindle (part # 03.825.002, lot # h052900) as the weld failed.The weld is cracked along its entire circumference which resulted in a loose shaft.The knob can be toggled with a light application of rotational force, the knob does not come completely undone.Disassembly of the device is still not possible.Although no definitive root-cause can be determined, it is possible that the device experienced unintended forces that lead to the weld failure.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 (b)(6) reports an event as follows: it was reported that on an unknown date the knob of the syncage evolution spindle has unscrewed from the shaft.When the knob is turned it unscrews from the shaft and the spindle cannot release the trial.An additional spindle was used to complete the surgery without patient consequence.Concomitant medical products: unknown trial spacer, (part # unknown, lot # unknown, quantity 1).Unknown evolution implant holder, (part # unknown, lot # unknown, quantity 1).This report is for one (1) syncage evolution spindle.This is report 2 of 2 for (b)(4).

• Brand Name: SYNCAGE EVOLUTION SPINDLE
• Common Device Name: MISC. ORTHO SURGICAL INSTR.
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9198463
• Report Number: 8030965-2019-69373
• Device Sequence Number: 16255259
• Product Code: LXH
• UDI-Device Identifier: 07611819542303
• UDI-Public: 07611819542303
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2019

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 Catalogue Number: 03.825.002
• Device Lot Number: H052900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 10/16/2019
• Patient Sequence Number: 1