MAUDE Adverse Event Report: SYNTHES GMBH SYNFIX EVOLUTION SCREWDRIVER STRAIGHT W/O SLEEVE; SCREWDRIVERS

Catalog Number	03.835.015
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
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is jnj representative.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 (b)(6) reports an event as follows: it was reported on an unknown date that newly received handle and screwdriver were defective.The new handle is blocked on the new screwdriver.It was unknown if there is any procedure and patient involvement.This complaint involves two (2) devices.This report is for (1) synfix® evolution screwdriver straight w/o sleeve.This report is 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.H3, h4, h6: product code: 03.835.015.Lot#: l094473.Manufacturing site: haegendorf.Release to warehouse date: 14.Sep.2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Product was not returned.Based on the information available, it has been determined that no corrective and 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.
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.D9 h3, h6: product code: 03.835.015 lot#: l094473 manufacturing site: haegendorf release to warehouse date: 14.Sep.2016 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the handle and the screwdriver were returned in assembled condition.The complaint description, which states that the devices are new cannot be confirmed, both devices are in a used condition, the handle has stress marks at the locking sleeve and marks of hammer blows on top.The tip of the screwdriver is in a very used condition with strong stress marks and the stardrive tip is worn.Functional inspection: it was possible to disassemble the devices during the investigation with some shaking movements.After the screwdriver was removed it was possible to assemble and disassemble the devices, but the assembly was tight.This tight assembly was caused by two points, first some very strong impression marks at the coupling end of the screwdriver and second by the rough-running coupling mechanism at the handle.Investigation conclusion: the complaint is rated as confirmed for the screwdriver as the strong impression marks below the cut-in of the coupling end have any influence on the assembly of the devices.The appearance of these ball shaped impression marks shows clearly that they were caused by the holding balls of the handle coupling.Such marks can only be caused when there are strong hammer blows applied onto the handle while the locking mechanism is not released.Based on that it has to be concluded that inappropriate handling did lead to the complained malfunction of the devices.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.The root cause was identified during the performed customer quality (cq) evaluation and therefore the in the investigation flow listed remaining investigation steps are not required.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: SYNFIX EVOLUTION SCREWDRIVER STRAIGHT W/O SLEEVE
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10985043
• Report Number: 8030965-2020-09573
• Device Sequence Number: 2636171
• Product Code: HXX
• UDI-Device Identifier: 07612334054364
• UDI-Public: (01)07612334054364
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 11/13/2020

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: 03.835.015
• Device Lot Number: L094473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 01/15/2021; 01/26/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 01/22/2021; 02/02/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HAND W/QUICK-COUPL SM