MAUDE Adverse Event Report: SYNTHES BRANDYWINE 4.0MM HEXAGONAL SCREWDRIVER; SCREWDRIVERS

Catalog Number	313.93
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reportedly there was no patient involvement.Date of event is unknown.Device is an instrument and is not implanted/explanted.A device history record review was performed for the subject device lot number a4jx517.Manufacturing location: (b)(6).Date of manufacture: june 10, 1999.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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
It was reported that two instruments were discovered damaged in sterile processing.The tip is broken off on one side of the screw forceps and the tip is bent on the 4mm hex screwdriver.There was no patient involvement.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Product development investigation was completed.A visual inspection under 5x magnification, device history record (dhr) review, and drawing review were performed as part of this investigation.This complaint is confirmed, as the hexagonal screwdriver is warped and the tip is no longer on the screw and plate holding forceps.The instrument is used in multiple procedures to remove 7.3mm cannulated screws; it is unclear from the complaint description which procedure the device was used in.The returned device shows wear around the tip of the hexagonal screwdriver.The material has been shifted out of plane on all six sides of the screwdriver head.The hexagon measurement from tip to tip was 4.54mm, 4.68mm, and 4.59mm which does not meet the specification of between 4.45-4.55mm.The hexagon measurement from side to side was 4.16mm, 4.53mm, and 4.23mm which does not meet the specification of between 4.00-4.02mm.The overall condition of the device was good, with no other defects other than the complaint condition.Replication of the complaint condition was not applicable as the device was received in damaged condition.Relevant drawings were reviewed.No drawing issues or discrepancies were noted.The design is adequate for its intended use and did not contribute to this complaint condition.Although details on the use of the devices are unknown, the multiuse devices are put under constant stress to perform their intended functions.The most likely root cause of the complaint conditions is repetitive use and reprocessing over the products¿ lifetime.No new, unique or different patient harms were identified as a result of this evaluation.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: 4.0MM HEXAGONAL SCREWDRIVER
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• MDR Report Key: 6583219
• Report Number: 2530088-2017-10097
• Device Sequence Number: 19020074
• Product Code: HXX
• UDI-Device Identifier: 10886982188243
• UDI-Public: (01)10886982188243(10)A4JX517
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2017

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: 313.93
• Device Lot Number: A4JX517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/05/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2017
• Supplement Report FDA Received Date: 06/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1