MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPINDLE FOR EVOLUTION; MISC ORTHO SURGICAL INSTR

Model 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
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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
Unknown event date/intraoperative date.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, 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 an unknown procedure a spindle for evolution instrument was not functioning properly.When the instrument is disengaged from the trial spacer the device leaves the head screws attached to the trial.The instrument is from a synfix loaner set.The procedure was completed successfully using the back up device in the set.No surgical delay.Concomitant device reported: unknown trial spacer (part #: unknown, lot #: unknown, quantity #: 1).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 investigation: the syncage evolution spindle (p/n: 03.825.002, lot #: h236312) was received at us customer quality (cq).Visual inspection of the complaint device showed the weld that joins the knob component to the spindle component was cracked and not holding the two components together.No other defects were identified.Functional test: a functional assessment was performed on the device, and the knob component can be screwed onto the spindle component but comes off very easily.The complaint was able to be replicated.Complaint confirmed? yes.Dimensional inspection: specified dimensions: spindle proximal end by weld: = 11.95 +0/-0.05mm.Measured dimensions: spindle proximal end by weld: = 11.93mm, conforming.Device used: caliper ca802.Specified dimensions: distal end of knob inside mating hole for spindle: = 12.05 +/- 0.05mm.Measured dimensions: distal end of knob inside the mating hole for spindle: = 12.05mm, conforming.Device used: caliper ca802.Document/specification review: no design issues or discrepancies were identified.Device history lot: part # 03.825.002.Synthes lot # h236312.Supplier lot # h236312.Release to warehouse date: 10 may 2017.Supplier: (b)(4).No ncr's were generated during production.Device history review : review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Investigation conclusion: this complaint is confirmed as the knob component will not stay on the spindle component since the joining weld is cracked.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.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.
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.B4: date of the report on initial med-watch was incorrectly reported as 10/16/2019.The correct date is 10/15/2019.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: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9262087
• Report Number: 2939274-2019-61870
• Device Sequence Number: 3671588
• Product Code: LXH
• UDI-Device Identifier: 10705034732022
• UDI-Public: (01)10705034732022
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 10/15/2019

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: 03.825.002
• Device Catalogue Number: 03.825.002
• Device Lot Number: H236312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 11/19/2019; 12/04/2019; 12/23/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 11/26/2019; 12/23/2019; 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - TRIALS