MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VERSE QUICK STICK, TUBE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	299704217
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2021
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 during a procedure on (b)(6) 2021, the connection part of the long quick stick sleeve was bent and could not be placed on the top notch of the screw.There was no patient impact.Replacement instruments were sufficiently available.Procedure was successfully completed without any surgical delay.This report is for (1) verse quick stick, tube.This is report 1 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: a review of the receiving inspection (ri) for verse quick stick, tube was conducted identifying that lot number gm5124505 was released in two batches.Batch1: lot qty of (b)(6) units were released on september 26, 2018 with no discrepancies.Batch2: lot qty of (b)(6) units were released on september 24, 2018 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.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: verse quick stick, tube (p/n: 299704217, lot #: gm5124505) was returned and received at us customer quality (cq).Upon visual inspection, the locking facilitator tube spring component on the device was observed to be bent inwards.Additionally, scratches were observed on the device.No other issues were observed with the returned device.Device failure/defect identified? yes.Dimensional inspection: a dimensional inspection was not performed as the complaint relevant components were inaccessible without destruction of the returned device document/specification review:(current and manufactured) expedium verse locking facilitator tube sub assembly : current and manufactured revisions were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion the complaint could be confirmed for the returned device.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied on the device.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: VERSE QUICK STICK, TUBE
• 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: 12077338
• Report Number: 1526439-2021-01321
• Device Sequence Number: 14343871
• Product Code: LXH
• UDI-Device Identifier: 10705034477190
• UDI-Public: (01)10705034477190
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• 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): 06/04/2021

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: 299704217
• Device Catalogue Number: 299704217
• Device Lot Number: GM5124505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 08/30/2021
• 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: UNKNOWN GUIDES/SLEEVES/AIMING; UNKNOWN SCREWS; UNKNOWN GUIDES/SLEEVES/AIMING; UNKNOWN SCREWS