MAUDE Adverse Event Report: SYNTHES GMBH 2.4/3.0MM CRUCIFORM SCRWDRVR BLADE WITH HEX COUPLING; SCREWDRIVER

Catalog Number	313.939
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2022
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 a j&j sales representative.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 depuy synthes reports an event in (b)(6) as follows: it was reported that during a procedure on (b)(6) 2022 there was a contact issue between screwdriver shaft and screws.The screwdriver was broken.The patient outcome is reported as okay.No further information provided.This report is for one (1) 2.4/3.0mm cruciform scrwdrvr blade with hex coupling.This is report 1 of 1 for complaint (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.H10 additional narrative: h6: the device lot number is unknown, therefore a device history review could not be performed.If more information become available, the record will be re-assessed.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the device from the received image.Visual analysis of the photo revealed that the scrdrivershaft-2.4/3 crucif not self-hol is broken from the tip.No other issue was found.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the scrdrivershaft-2.4/3 crucif not self-hol.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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: 2.4/3.0MM CRUCIFORM SCRWDRVR BLADE WITH HEX COUPLING
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 14147448
• Report Number: 8030965-2022-02540
• Device Sequence Number: 2932056
• Product Code: HXX
• UDI-Device Identifier: 07611819725621
• UDI-Public: (01)07611819725621
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 313.939
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2022
• Supplement Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK-SCREWS
• Patient Sex: Unknown