MAUDE Adverse Event Report: SYNTHES HAGENDORF CRUCIFORM SCREWDRIVER; SCREWDRIVERS

Catalog Number	313.96
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.During the investigation of the device on january 12, 2017, it was found that the tip was broken.Device is an instrument and is not implanted/explanted.A device history record review was performed for the subject device lot.Manufacturing location: (b)(4); manufacturing date: 29 october 2008.No non-conformances were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.A product development investigation was performed for the subject device.The returned screwdriver (part# 313.96, lot# 1983862) has a broken tip with fragments missing.1 of the 4 prongs remains, but is bent.No other issues were noted with the device.A visual inspection and drawing review were performed as part of this investigation.The complaint is confirmed.Replication of the complaint condition is not applicable as the device is already broken.The following drawings were reviewed during investigation: cruciform screwdriver assy - 313_96.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 parts were determined to be suitable for the intended use when employed.No definitive root cause was able to be determined.The root cause is likely related to application of excessive force during screw removal.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
During a revision surgery on (b)(6) 2016, to remove a generation dorsal distal radius plate (pi plate) and screws, the surgeon could not remove the plate until he burred off the heads of all screws.Three screw heads remain implanted and all screw shafts remain implanted because the surgeon could not remove them.In an attempt to remove the screws, two burr round devices, one burr egg, and a screwdriver were stripped.He was able to bend and loosen the plate and explant most of it because the plate eventually broke.Surgery was delayed approximately 90 minutes.One piece of the plate remained in the radius.It was stated that the surgery proceeded as normal after the delay in hardware removal.Patient is in a stable condition.Concomitant medical products: holding sleeve (part# 313.97, lot# 3057596, quantity 1); air pen drive (part# unknown, lot# unknown, quantity 1).This is report number 3 of 3 for complaint (b)(4).

• Brand Name: CRUCIFORM SCREWDRIVER
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6269477
• Report Number: 3003875359-2017-10034
• Device Sequence Number: 1003842
• Product Code: HXX
• UDI-Device Identifier: 10887587037189
• UDI-Public: (01)10887587037189(10)1983862
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 11/30/2016

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: 313.96
• Device Lot Number: 1983862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2017
• Initial Report FDA Received Date: 01/23/2017
• 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: 1 X AIR PEN DRIVE PART# UNKNOWN; 1 X HOLDING SLEEVE PART# 313.97
• Patient Age: 50 YR