MAUDE Adverse Event Report: SYNTHES HAGENDORF STRAIGHT TIP T25 DRIVER STANDARD; SCREWDRIVERS

Catalog Number	03.632.400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient¿s identifier, date of birth and weight are not available for reporting.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.(b)(6).A device history record (dhr) review was performed for part # 03.632.400, lot # 9069558: manufacturing location: (b)(4), manufacturing date: 05.Sep.2014: no non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 reports an event in (b)(6) as follows: it was reported that during a lumbar spinal fusion on (b)(6) 2017, the distal tip of two screwdriver shafts were damaged when a surgeon attempted to remove a set screw (locking cap) from the head of a polyaxial matrix screw to adjust the polyaxial matrix screw after it had been final tightened.One of the screwdriver shafts broke into two or three pieces, and the other one became bent.There were no fragments of the broken screwdriver left in the patient, and all pieces will be returned.There was no surgical delay, and the procedure was successfully completed with a like instrument.Reported concomitant devices: polyaxial matrix screw: (qty.1).Matrix locking cap (part # 04.632.000, qty.1).This report is for one (1) straight tip t25 driver standard.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
The device has been received and the product evaluation is in progress.No conclusion can be drawn.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 devices.Part number: 03.632.400, lot number: 9069558 the screwdriver tip is broken in a spiral fracture pattern.Two broken tip fragments were returned along with the screwdriver.Measurements of the tip feature could not be obtained due to the broken and fragmented condition.The complaint is confirmed.Replication is not applicable as the tip is already broken.Dhr review: part # 03.632.400, lot # 9069558.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the products, and any subcomponents, material or hardness, which would contribute to this complaint condition.No additional malfunctions were observed during investigation.The following drawings were reviewed during investigation.Screwdriver shaft, matrix straight tip driver non-standard t25 straight.The design history was not found to impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.No definitive root cause was able to be determined.It is unknown if the 10nm torque limiting attachment was used to tighten the screws; however, if the attachment was not used, it may have resulted in overtightening leading to difficulty removing the screw.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: STRAIGHT TIP T25 DRIVER STANDARD
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6969109
• Report Number: 3003875359-2017-10528
• Device Sequence Number: 16371921
• Product Code: HXX
• UDI-Device Identifier: 10705034719917
• UDI-Public: (01)10705034719917(10)9069558
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2017

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: 03.632.400
• Device Lot Number: 9069558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Initial Date Received by Manufacturer: 10/02/2017
• Supplement Date Received by Manufacturer: 11/02/2017; 11/29/2017
• Initial Report FDA Received Date: 10/23/2017
• Supplement Report FDA Received Date: 11/20/2017; 11/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1