MAUDE Adverse Event Report: SYNTHES GMBH SYNFRAME INSULATED TABLE CLAMP; MISC ORTHO SURGICAL INSTR

Catalog Number	387.346
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Event date unknown.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is jnj employee.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received.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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported on(b)(4) 2021 that during an investigation it was noticed that the black screws are too light and cannot be turned properly even after lubrication.It was unknown if there was any procedure and patient involvement.This complaint involves two (2) devices.This report is for (1) synframe insulated table clamp.This report is 1 of 2 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, h4, h6: part: 387.346.Lot: bag1082.Manufacturing site: hägendorf.Release to warehouse date: april 30, 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the synframe holding base insulated f/or tab was received at us customer quality (cq).Visual inspection of the complaint device showed no external damage.Functional test: a functional assessment was performed on the complaint device.The black screws were able to tighten and loosen without any issues.The complaint was not able to be replicated.Dimensional inspection: a dimensional inspection was not performed since it was not applicable to the complaint condition.Document/specification review: current and manufactured revisions were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is not confirmed as the functional issue was unable to be replicated.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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: SYNFRAME INSULATED TABLE CLAMP
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11557936
• Report Number: 8030965-2021-02232
• Device Sequence Number: 19794581
• Product Code: LXH
• UDI-Device Identifier: 07611819141261
• UDI-Public: (01)07611819141261
• 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): 02/23/2021

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 Catalogue Number: 387.346
• Device Lot Number: BAG1082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 04/26/2021
• 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: SYNFRAME HOLDING BASE INSULATED F/OR TAB