MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC SPORT GRIP T25 STARDRIVE SHAFT F/MATRIX-STANDARD; SCREWDRIVERS

Catalog Number	03.632.005
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
Implant and explant dates: 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.Initial reporter is (b)(6) sales consultant.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 the distal end of two (2) separate sport grip t25 stardrive screwdriver shafts are slightly stripped.It was also noted the screwdriver sleeve has a metal ring damage, suspected to be due to wear and tear.Issue was discovered while scrub nurse was setting up prior to surgery, no patient involvement.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Part 03.632.005, lot 7901801: release to warehouse date: july 24, 2015.Manufactured by (b)(4).No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.A product investigation was completed: per the technique guide, the sport grip t25 stardrive (03.632.005) is utilized in the matrix posterior pedicle screw, hook and rod fixation system.The driver is specifically utilized for screw and locking cap insertion.The returned driver was examined and the complaint condition was able to be confirmed as the distal driver tip was found to be deformed.Additionally, all six of the lobes were found to be broken and missing a fragment.No definitive root cause was able to be determined; the failure mode is consistent with incorrect technique/application of excessive force.The complaint condition was unable to be replicated due to post-manufacturing damage.Relevant drawings for the returned instrument were reviewed (both current revision and from the time of manufacture.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.No dimensional analysis was able to be completed due to post-manufacturing damage.A device history review, including material and hardness reviews, was performed for the returned instrument¿s lot number and no material review reports, non-conformance reports or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.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
When the device was received by the manufacturer, it was noted that the distal threads were partially broken off the holding sleeve.It was also noted that the screwdriver tips have some small gouges in them.This is report 2 of 3 for (b)(4).

• Brand Name: SPORT GRIP T25 STARDRIVE SHAFT F/MATRIX-STANDARD
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7087854
• Report Number: 2939274-2017-50164
• Device Sequence Number: 13815512
• Product Code: HXX
• UDI-Device Identifier: 10705034718705
• UDI-Public: (01)10705034718705(10)7901801
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2017

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: 03.632.005
• Device Lot Number: 7901801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 12/18/2017
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 01/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1