MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH QUICK CONNECT HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	286522000
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.Without a lot number the device history records review could not be completed.Product was not returned.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 (b)(6) reports an event as follows: it was reported that during inspection on an unknown date, the quick-release fastener jammed; instrument pick-up is no longer possible.There was no surgery or patient impact.This report is for a quick connect handle.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: a product investigation was conducted.Visual inspection: the quick connect handle (part # 286522000 lot # 0410k) was received at us cq.Upon visual inspection, there were no defects were observed with the device.Functional test: the device was received by itself so the complete functional test was not performed.However, there was a gap observed between coupling and handle.The coupling is unable to close completely and gets stuck.This could have contributed to the complaint condition.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Conclusion: the complaint is confirmed for the received quick connect handle (part # 286522000 lot # 0410k).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.A review of the receiving inspection (ri) for quick connect handle was conducted identifying that lot number 0410k was released in five batches.Batch1: lot qty of (b)(4) units were released on 20 may 2010 with no discrepancies.Batch2: lot qty of (b)(4) units were released on 16 may 2010 with no discrepancies.Batch3: lot qty of (b)(4) units were released on 28 mar 2010 with no discrepancies.Batch4: lot qty of (b)(4) units were released on 10 jun 2010 with no discrepancies.Batch5: lot qty of (b)(4) units were released on 16 jun 2010 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.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: QUICK CONNECT HANDLE
• 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: 12331049
• Report Number: 1526439-2021-01714
• Device Sequence Number: 16818263
• Product Code: LXH
• UDI-Device Identifier: 10705034212999
• UDI-Public: (01)10705034212999
• 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): 07/19/2021

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: 286522000
• Device Catalogue Number: 286522000
• Device Lot Number: 0410K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1