MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH DRILL GUIDE MODULAR HANDLE; MISC ORTHO SURGICAL INSTR

Model Number	2020-00-119
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
Without a lot number the device history records review could not be completed.Product was not returned.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 an unknown date , the instrument room technician was assembling the drill guide handle and the inner locking shaft would not lock into place.No patient involvement.This report is for one (1) symphony oct system drill guide modular 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.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.H3, h6: a review of the receiving inspection (ri) for drill guide modular handle was conducted identifying that lot number km880958 was released in a single batch.Batch1: lot qty of (b)(4) units were released on 24 jul 2019 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 drill guide modular handle (part #: 202000119, lot #: km880958) was received disassembled at us customer quality (cq).Visual inspection of the complaint device showed that the plunger assembly was over molded with the knob.No missing component was observed.Functional test: a functional assessment was perform by trying to assemble the received components.The plunger assembly was not able to assemble and stay locked with the overmolded small handle and shaft.Can the complaint be replicated with the returned device? yes.Dimensional inspection.Measured dimensions.Shaft od: conform.Locking feature od: conform.Document/specification review: current and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the complaint device was received disassembled and unable to be assembled back.No root cause could definitively be determined for the reported complaint condition but it is likely internal component failure occurred.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 preventive 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: DRILL GUIDE MODULAR HANDLE
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle MA 02400 ; SZ 02400
• MDR Report Key: 11797795
• Report Number: 1526439-2021-00925
• Device Sequence Number: 17194343
• Product Code: LXH
• UDI-Device Identifier: 10705034530413
• UDI-Public: (01)10705034530413
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 04/14/2021

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: 2020-00-119
• Device Catalogue Number: 202000119
• Device Lot Number: KM880958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 05/19/2021; 06/08/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 06/04/2021; 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1