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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH STARDRIVE SCREWDRIVER SHAFT QC/T15; SCREWDRIVERS
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OBERDORF SYNTHES PRODUKTIONS GMBH STARDRIVE SCREWDRIVER SHAFT QC/T15; SCREWDRIVERS Back to Search Results
Catalog Number 314.116
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Patient information is unknown.It is unknown when the tip of the driver became distorted.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Lot: 7736557; manufacturing quantity 55; manufacturing location: universal punch (incoming inspection & packaging in monument); manufacturing date: august 14, 2013; stardrive screwdriver shaft t25/ self-retaining 165mm all inspection requirements were performed and passed.Certificate of conformance indicated that product was manufactured to specifications per product drawing and purchase order.Carpenter provided certificate of tests indicating that material was processed and passed test requirements per purchase order and specification requirements.No nonconformance reports (ncrs) or reworks were generated during production.Review of the device history record showed that there were no issued during the production of this product that would contribute to this complaint condition.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 Description
Device report from synthes europe reports an event in (b)(4) as follows: it was reported that open reduction internal fixation (orif) was applied to fibular fractures on (b)(6) 2018.It was intraoperatively found that the tip of driver had been distorted, so the surgeon could not connect the driver with screws.The surgery was completed without a delay.There was no adverse consequence to the patient.Concomitant devices: trauma screws (part: unknown, lot: unknown, quantity: unknown).This report is for a stardrive screwdriver shaft qc/t15.This is report 1 of 1 for (b)(4).
 
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.Patient ethnicity is unknown.Investigation site: cq zuchwil; selected flow 3: damage / twisted / deformed visual investigation: the tip of the distal t8 tip is heavily twisted (approximately 40 degrees) in the direction of screw removal.The star drive flanks show damage/deformation at a length of approx.1mm from the tip.Dimensional inspection: because of the damage of the complaint relevant dimensions of the t8 star drive tip, a dimensional inspection cannot be conducted and is not required per selected investigation flow because of use related damage.Drawing/specification review: the investigation has shown that the cause of the malfunction is a damage to the device after manufacture, therefore no drawing / specification test is required per selected investigation flow because of use related damage.Conclusion: the received condition agrees with the complaint description; the complaint therefore is confirmed.Visually there does not appear to be an issue other than the damage sustained by a mechanical overloading situation during screw extraction.The dhr reviews show that the devices met the specifications at the time of manufacturing and distributing.Lot 7736557 was manufactured in august 2013; 55 parts according to our specifications.We are not aware of any quality issues associated with this article and lot number.The complaint condition for the stardrive screwdriver shafts was likely caused by excessive torque during screw removal.No manufacturing related issue was identified and/or confirmed.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.
 
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.Corrected data: (date received by manufacturer) for mwr-12072018-0000150235 (follow-up 1) should be (b)(6) 2018.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.
 
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Brand Name
STARDRIVE SCREWDRIVER SHAFT QC/T15
Type of Device
SCREWDRIVERS
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key7586787
MDR Text Key110621777
Report Number8030965-2018-54246
Device Sequence Number1
Product Code HXX
UDI-Device Identifier07611819740877
UDI-Public(01)07611819740877
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 05/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number314.116
Device Lot Number7736557
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2018
Date Manufacturer Received07/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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