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 Patient Involvement (2645)
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 a company representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 during inspection of devices at the storage facility the welding seam from head to shaft is broken off two (2) syncage spindle instruments.The head can now be moved and turned which leaves the devices nonfunctional.There was no patient involvement.This is report 2 of 2 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.Investigation flow: damage.Visual inspection: the syncage evolution spindle (p/n:03.825.002, lot #: h052900) was returned and received at us cq.Upon visual inspection, it was observed that the weld connecting the knob with the spindle was broken allowing the knob to rotate and disassemble from the spindle.There were scratches on the device but has no impact on the functionality of the device.Device failure/defect identified? yes.Dimensional inspection: the dimensional inspection was performed on the returned device.Document/specification review based on the date of manufacture the drawings are reflecting the current and manufactured revision were reviewed complaint confirmed? yes, the device received was broken.Hence confirming the allegation.Investigation conclusion the complaint condition is confirmed for the syncage evolution spindle (p/n:03.825.002, lot #: h052900).There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.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 history lot manufacturing location: supplier - (b)(4), packaged and released by: monument, release to warehouse date: jul 13, 2016, part number: 03.825.002, spindle for evolution, lot number: h052900 (non-sterile), lot quantity: 58.Work order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection ns069512 rev b met all inspection acceptance criteria.Certificate of compliance received from avalign dated jul 06, 2016 was reviewed and determined to be conforming.Packaging label log lppf, lmd/lpf rev aa was reviewed and determined to be conforming.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Device history review.Dec 27, 2019: dhr reviewed this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that 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.

• 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: 9595703
• Report Number: 8030965-2020-00394
• Device Sequence Number: 3174942
• Product Code: LXH
• UDI-Device Identifier: 07611819542303
• UDI-Public: (01)07611819542303
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Date (Section B): 12/19/2019

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: 01/13/2020
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1