MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 2.0MM SCREWDRIVER BLADE/SELF- RETAINING/STARDRIVE(TM)/SHORT; SCREWDRIVERS

Model Number	313.842
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a 2.0mm screwdriver blade-self-retaining-stardrive-short was found stripped in the reprocessing area without any information.It is unknown when the malfunction occurred or if there is patient involvement.This is report 1 of 1 for (b)(4).

• Brand Name: 2.0MM SCREWDRIVER BLADE/SELF- RETAINING/STARDRIVE(TM)/SHORT
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7201594
• Report Number: 2939274-2018-50301
• Device Sequence Number: 19151722
• Product Code: HXX
• UDI-Device Identifier: 10887587036878
• UDI-Public: (01)10887587036878(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 12/22/2017

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 Model Number: 313.842
• Device Catalogue Number: 313.842
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/22/2017
• Initial Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1