MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC CRUCIFORM SCREWDRIVER; SCREWDRIVERS

Catalog Number	313.96.96
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient involvement was reported.Date of event: date of device breakage is not known.(b)(4) lot unknown.Device is an instrument and is not implanted/explanted.Without a lot number the device history records review could not be completed.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 or Problem Description
It was reported that the tip is broken off on a cruciform screwdriver.This was discovered in sterile processing.No known procedure involvement.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Corrected data: manufacturer name, city and state.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.
Additional Manufacturer Narrative
Customer quality conducted an investigation of the returned device.The screwdriver tip has two of the flanges broken off.The remaining flanges are twisted and deformed in the direction of screw removal.The handle has a chip missing from the proximal end and there are multiple small cracks in the handle.The complaint is confirmed.Replication of the complaint condition is not applicable as the device is already broken.The returned screwdriver is etched with part number 313.96.96, with no lot number etched.The device was determined to be made to drawing revision g.The drawing was updated to allow for 313.96.96 to be etched on the part.Later revision added a requirement to etch the lot number on the device.Based on this the device was manufactured between june 1996 and february 1997.Making the device over 20 years old.The drawings were reviewed during investigation.There is no indication that material or hardness issues contributed to the complaint condition as the device was in use for over 20 years.Dimensional inspection of the broken tip could not be performed due to the post manufacturing damage.No dhr review could be completed as the lot number is unknown.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CRUCIFORM SCREWDRIVER
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7083395
• Report Number: 8030965-2017-50313
• Device Sequence Number: 19057540
• Product Code: HXX
• UDI-Device Identifier: 10886982188274
• UDI-Public: (01)10886982188274(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2017

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: 313.96.96
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 12/08/2017; 01/02/2018
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 01/02/2018; 01/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1