MAUDE Adverse Event Report: SYNTHES GMBH SCREWDRIVER HANDLE WITH HEX COUPLING-MEDIUM; SCREWDRIVERS

Catalog Number	311.006
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.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.Investigation summary.Photo investigation: the complaint device was not returned for investigation.A photo investigation was completed based on the images provided.The center shaft of the screwdriver along with the shaft clamp had broken off from the inside the screwdriver handle.A definitive assignable root cause cannot be identified.Manufacturing record evaluation could not be performed as no lot number information was available.Since the part was returned, an as-received and dimensional inspection could not be performed.Conclusion: the complaint condition can be confirmed based on the available information.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history review: dhr could not be performed as no lot number information was available.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 (b)(6) 2021, the screwdriver handle dislodged and could not be used.The procedure was successfully completed without surgical delay.There was no patient consequence.This report is for one (1) screwdriver handle with hex coupling-medium.This is report 1 of 1 for (b)(4).

• Brand Name: SCREWDRIVER HANDLE WITH HEX COUPLING-MEDIUM
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12369955
• Report Number: 8030965-2021-07221
• Device Sequence Number: 1179965
• Product Code: HXX
• UDI-Device Identifier: 07611819753389
• UDI-Public: (01)07611819753389
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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
• Report Date (Section B): 07/30/2021

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: 311.006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1