MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS ALIGNMENT DEVICE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	279726400
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2021
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, 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 that on (b)(6) 2021, intraoperatively it was noticed that the tip of the instrument was bent.As a result no single disposable cement cannula can be used.No allegation against item.Surgery was completed successfully.Another instrument was used to complete the surgery without any patient consequences.Concomitant device reported: cement cannula (part# 279726508, lot# unknown, quantity unknown).This report is for one (1) viper system alignment device.This is report 1 of 1 for complaint (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.H3, h4, h6: a review of the receiving inspection (ri) for mis alignment device was conducted identifying that lot number gm4814001 was released in two batches.Batch1: lot qty of (b)(4) units were released on 27 jun 2017 with no discrepancies.Batch2: lot qty of (b)(4) units were released on 27 jun 2017 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Visual inspection: the mis alignment device (product code: 279726400, lot #: gm4814001) was received at us customer quality (cq).Upon visual inspection at cq, the distal tip of the device had some scratches and the threads were stripped.No other issues were identified during the visual inspection.Device failure/defect identified? yes.Dimensional inspection: dimensional inspection cannot be performed due to post-manufacturing damage.Documentation/ specification review: the following current and manufactured revisions were reviewed: viper mis alignment device assembly, no design issues or discrepancies were found during this investigation.Complaint confirmed? yes.Investigation conclusion: the complaint can be confirmed as the mis alignment device (product code: 279726400, lot #: gm4814001).No definitive root cause can be determined based on the provided information.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.

• Brand Name: MIS ALIGNMENT DEVICE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 12549981
• Report Number: 1526439-2021-02087
• Device Sequence Number: 3913322
• Product Code: LXH
• UDI-Device Identifier: 10705034199481
• UDI-Public: (01)10705034199481
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2021

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: 279726400
• Device Catalogue Number: 279726400
• Device Lot Number: GM4814001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 11/01/2021
• 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: FEN MIS CANNULA STRL; MIS ALIGNMENT DEVICE