MAUDE Adverse Event Report: SYNTHES BRANDYWINE 1.5MM/2.0MM CRUCIFORM SCREWDRIVER BLD W/HOLDING SLV; SCREWDRIVERS

Catalog Number	314.67.96
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Dhr review for part # dhr review for: part #314.67.96 - lot #4333343 ; release to warehouse date: 25-oct-2001; expiration date: na ; supplier: synthes (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.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 while cleaning a synthes 1.5mm / 2.0mm cruciform screwdriver blade with holding sleeve, the sterile processing staff was unable to remove the inner "grasping" part from the outer tube.After several attempts and with the aid of a pair of pliers, the staff was able to separate the parts and realized that the inner portion of the device was bent.The pieces can no longer be assembled.There was no patient involvement or procedure ongoing and the issue was discovered outside of the operating room.This complaint involves one (1) device: 1.5mm / 2.0mm cruciform screwdriver with one part data.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product development investigation has been 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.The returned device was received in two pieces and the device is bent as reported.The proximal coupling end on the inner shaft has prongs that are bent outward and twisted approximately 5-10 degrees in counter-clockwise direction.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already bent.Drawings were reviewed during this investigation.No product design issues or discrepancies were observed.The root cause was determined as most likely due to cumulative wear or aggressive handling on this 15+ year old reusable instrument.No new, unique or different patient harms were identified as a result of this evaluation.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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: 1.5MM/2.0MM CRUCIFORM SCREWDRIVER BLD W/HOLDING SLV
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• MDR Report Key: 6347986
• Report Number: 2530088-2017-10051
• Device Sequence Number: 38334
• Product Code: HXX
• UDI-Device Identifier: 10886982188991
• UDI-Public: (01)10886982188991(10)4333343
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 01/25/2017

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: 314.67.96
• Device Lot Number: 4333343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/25/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2017
• Supplement Report FDA Received Date: 03/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1