MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.0MM STARDRIVE SCRWDRVR BLADE W/SPRG HLDG SLV SHRT/66MM MQC; SCREWDRIVERS

Catalog Number	314.676
Medical Device Problem Codes	Material Twisted/Bent (2981); Naturally Worn (2988)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.Occupation: reporter is a j&j rep.Without a lot number, the device history records review could not be completed as no product was received.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: the staff in the hospital reported that the self-capture was not picking up the screws.They managed to get the 1.5 screwdriver which is the same type working therefore it was not user error.I have asked that if possible it is cleaned and sterilised and handed to me so that i can return it.The surgery was completed with a small delay.Concomitant device reported: unknown screws (part # unknown, lot # unknown, quantity # unknown).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).
Event or Problem Description
It was further reported that screwdriver did not appear to be damaged, it is just worn.
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, h4, h6: 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.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.

• Brand Name: 2.0MM STARDRIVE SCRWDRVR BLADE W/SPRG HLDG SLV SHRT/66MM MQC
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9484078
• Report Number: 8030965-2019-71172
• Device Sequence Number: 234588
• Product Code: HXX
• UDI-Device Identifier: 07611819771314
• UDI-Public: (01)07611819771314
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/26/2019

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: 314.676
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 12/30/2019; 02/03/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 01/21/2020; 02/14/2020
• 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: UNK - SCREWS: TRAUMA