MAUDE Adverse Event Report: SYNTHES MONUMENT T4 TORX SCREWDRIVER BLADE HEX COUPLING; SCREWDRIVERS

Catalog Number	03.505.217
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Sedation (2368)
Date of Event	06/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Patient dob and weight not provided for reporting.Device is an instrument and is not implanted/explanted.Concomitant devices: therapy dates: (b)(6) 2017.Va locking screw (part # 02.130.211, lot# unknown, qty 1) note; this screw was the screw the fragment was embedded in to va locking screw (part # 02.214.111, lot# unknown, qty 1).Device history records review was conducted.The report indicates that the: dhr review for part #03.505.217, synthes lot#9911203.Release to warehouse date: 25-nov-2015.Expiration date: n/a.Supplier: (b)(4).No ncrs were generated during production.Review of the device history record 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 during a right 5th phalange fracture repair on (b)(6) 2017 that a screwdriver blade tip broke off into a 1.5 mm variable locking screw.It was during the insertion of the locking screw (2nd screw), the tip of the t4 torx screwdriver blade broke off into the head of the screw.The first 1.5mm cortex screw had been inserted without incident.The surgeon attempted removal of the broken screwdriver tip.The surgeon tried using the synthes universal screw removal set and was unable to grab the fragment because the head of the screw contained the broken screwdriver tip and the screw could not be backed out.A second screw removal set was also used to try and remove the fragment but was unsuccessful in removal.There was a surgical delay of 1 hour was noted.The surgical delay was caused by trying to locate another t4 torx screwdriver blade and five (5) minutes of the delay was from the attempted screw removal.Another t4 screwdriver was not available and the surgeon had to switch from the 1.5mm va locking screws to the 2.0mm cortex screws (non-locking) and used the t6 screwdriver for screw insertion.The procedure was completed successfully by using 2.0 mm cortex screws.Patient was implanted with a metacarpal plate, two (2) 1.5mm locking screws and six (6) 2.0mm cortex screws.The surgeon was satisfied with the stability of the construct.The patient was reported as stable.This complaint is 1 device concomitant devices: va locking screw (part # 02.130.211, lot# unknown, qty 1) note; this screw was the screw the fragment was embedded in to va locking screw (part # 02.214.111, lot# unknown, qty 1) plate (part# 02.130.263 lot# unknown, qty 1) this report is 1 of 1 for com-(b)(4).
Additional Manufacturer Narrative
Product development investigation was completed.A visual inspection, device history record (dhr) review and drawing review were performed as part of this investigation.This complaint is confirmed for the tip of the returned screwdriver blade was broken and missing.The balance of the devices is in a good and functional condition with no signs of wear.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned instrument is already damaged.Relevant drawings were reviewed during this investigation.Approx.1.8 mm of the device tip was broken and missing.The diameter of the device feature that immediately precedes the engaging tip was measured using calipers within specification at 1.39 mm (spec: 1.4 mm +0/-0.1).The damage to the devices is most likely due to rough handling during operation.Application of excessive or off-axis force to the device may also contribute to breakage of the screwdriver tip.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.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: T4 TORX SCREWDRIVER BLADE HEX COUPLING
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6729138
• Report Number: 1719045-2017-10669
• Device Sequence Number: 653012
• Product Code: HXX
• UDI-Device Identifier: 10887587014012
• UDI-Public: (01)10887587014012(10)9911203
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.505.217
• Device Lot Number: 9911203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2017
• Supplement Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 07/20/2017
• Supplement Report FDA Received Date: 08/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 14 YR