MAUDE Adverse Event Report: SYNTHES BRANDYWINE STAR/HEXDRIVE SCREWDRIVER T25 3.5MM HEX/SELF-RETAINING; SCREWDRIVERS

Catalog Number 03.010.150

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No patient involvement reported.Device history records review was completed for part # 03.010.150, lot # 5140053.Release to warehouse date: jan 05, 2006, manufactured by: synthes (b)(4).No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device was received and the product evaluation is in progress.No conclusion can be drawn.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

It was reported that during the sterile processing, the tip of the screwdriver was found to be twisted.It is unknown how or when this occurred.No procedure or patient involvement was reported.This report is for one (1) screwdriver.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A product development investigation was performed for the t25 hexdrive screwdriver (part number 03.010.150, lot number 5140053).The subject device was returned with the complaint condition stating the tip on the returned screwdriver is twisted approximately 45 degrees in the direction of resistance met during screw extraction.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the tip of the returned screwdriver is already twisted.This complaint is confirmed.A visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.No non-conformance records were generated during production.Review of the device history records showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.Drawings were reviewed during investigation.The design history was not found to impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.No definitive root cause was able to be determined.The root cause is most likely related to application of excessive torque during screw extraction on the driver if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: STAR/HEXDRIVE SCREWDRIVER T25 3.5MM HEX/SELF-RETAINING
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6129435
• MDR Text Key: 60945169
• Report Number: 2530088-2016-10329
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.150
• Device Lot Number: 5140053
• Other Device ID Number: (01)10886982067975(10)5140053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1