MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH STARDRIVE SCREWDRIVER SHAFT QC/T15; SCREWDRIVERS

Catalog Number 314.116

Device Problems Kinked (1339); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information not available for reporting.Device is an instrument and is not implanted/explanted.A review of the device history records has been requested.Subject device has been received and is currently in the evaluation process.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)(6) as follows: it was reported patient underwent an open reduction internal fixation (orif) for right proximal tibia plateau fractures on (b)(6) 2018.During insertion of a locking screw, the tip of the stardrive screwdriver shaft would not connect to the screw head.It was noted the tip of the screwdriver shaft was kinked.Surgery was completed with no delay utilizing a replacement instrument.No adverse consequence to the patient was reported.Concomitant device reported: locking screw (part number unknown, lot number unknown, quantity 1).This report is for one (1) stardrive screwdriver shaft.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.Dhr review was completed.Part number: 314.116 synthes lot number: 7867532 supplier lot number: n/a release to warehouse date: 21-may-2015 expiration date: n/a manufactured by synthes monument no ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.H3, h6: customer quality conducted an investigation of the returned device.As received condition: the tip of the complained screw driver is twisted in counter-clockwise direction.Therefore it is no longer possible to the counterpart screw head.Therefore this complaint is classified as confirmed.It is obvious that the tip of the screw driver is twisted in counter-clockwise direction this is clear indication that the damage occurred during screw removal procedure and not during current use as described.In screw removal procedures often exceeding torsional forces are required.We have to assume that mechanical overloading situation during removal caused the damage of the tip.Due to the damages, it is not possible to measure the relevant dimensions in this area, however as this part was released after final inspection and due to the identified damages we exclude manufacturing issue as root cause for the damage.Mechanical overloading during use could be identified as root cause for the failure.No product failure could be identified.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.

• 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 Key: 7527754
• MDR Text Key: 108731688
• Report Number: 8030965-2018-53868
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 07611819740877
• UDI-Public: (01)07611819740877
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 314.116
• Device Lot Number: 7867532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Date Manufacturer Received: 05/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1