MAUDE Adverse Event Report: SYNTHES MONUMENT STARDRIVE SCREWDRIVER SHAFT T4/66MM; SCREWDRIVERS

Catalog Number	03.114.010
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.Dhr review for part # 03.114.010, synthes lot # 7766505 release to warehouse date: 14-dec-2014 expiration date: na manufactured by: (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.Customer quality (cq) engineering investigation: this complaint is confirmed.A functional test at cq confirmed the reported complaint condition.The returned stardrive screwdriver would not seat into any of the 10 small drill guides at cq.The complaint condition was able to be replicated at customer quality (cq).No new malfunctions were identified as a result of the investigation.However, a failure code of "malformed : bent/distorted/warped" was selected for this investigation summary to account for the as received condition of the screwdriver shaft which has post manufacturing wear/damage device 1 of 2 the distal stardrive tip is malformed/worn and no longer has defined edges.Most likely due to cumulative wear.Dhr review for part # 03.114.010, synthes lot # 7766505.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.The material and relevant material properties were determined to be conforming at the time of manufacture based on review of the dhr.A dimensional inspection was not able to be accurately performed at cq due to the post manufacturing wear/damage.Drawing was reviewed during this investigation.The design specifies a stardrive/t4 recess which matches the profile for the mating drill guides.No product design issues or discrepancies were observed.Most likely due to cumulative wear for the returned stardrive screwdriver which in turn stripped the screw head recesses on the returned y plate with drill guides.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 during a surgical procedure on (b)(6) 2017, a stardrive screwdriver was not able to remove the drill guide from a 1.5 mm locking compression plate (lcp)-y plate with guides.The plate in general has pre-loaded drill guides which could not be removed by the screwdriver before the plate was implanted in the patient.The plate was reported to be intact, whereas the stardrive screwdriver did not show any visible deformation or other physical faults.Failing the attempt of removing the drill guide, a different plate was used.It is unclear if the same or a different screwdriver was used in the procedure.The procedure was completed successfully with an approximate two (2) minute surgical delay.The patient is reported to be in stable condition.Returned device was evaluated by customer quality on (b)(6) 2017.Complaint was reassessed based on that evaluation and deemed to be a reportable event.This report is for one (1) stardriver screwdriver shaft t4/66mm.This is report 1 of 1 for (b)(4).

• Brand Name: STARDRIVE SCREWDRIVER SHAFT T4/66MM
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6998288
• Report Number: 1719045-2017-11144
• Device Sequence Number: 1292576
• Product Code: HXX
• UDI-Device Identifier: 10886982073044
• UDI-Public: (01)10886982073044(10)7766505
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 09/08/2017

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: 03.114.010
• Device Lot Number: 7766505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 11/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR