MAUDE Adverse Event Report: SYNTHES SELZACH 2.7MM CANNULATED DRILL BIT/QC 2.7MM CANNULATED DRILL BIT/QC; INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH

Catalog Number 310.670

Device Problem Dull, Blunt (2407)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient date of birth and weight are provided for reporting.Date of event when the device malfunctioned is unknown.Additional device product codes: gfa, gff, hsz.Device is an instrument and is not implanted / explanted.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.(b)(6).Device history records review was completed for part # 310.670, lot # f-16958.Manufacturing location: (b)(4), manufacturing date: mar 24, 2015.No non conformance reports were generated during production.Review of the device history records 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 Description

Device report from synthes europe reported an event in (b)(6) as follows: it was reported that during surgery on (b)(6) 2017, the drill bit was would not cut; it was blunt.Additionally, upon the return of the surgery box to the stock point, it was noted that one more device was worn out.There was no prolongation of the surgery was reported and the patient outcome was good.This report is for one (1) cannulated drill bit.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

The subject device has been received by the manufacturer and is undergoing investigation.The results of the investigation are pending completion and will be submitted in a supplemental report.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.

Manufacturer Narrative

Product development investigation was completed.Two drill bits were received.The received drill bits were found with blunt cutting edges.Furthermore there are nicks and wear and tear signs on both drill bits surfaces.The manufacturing review of both received drill bits shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.As indicated in the manufacturing documents for lot f-16958, the hardness was with the measurement of a minimum of (b)(6).For lot 1165595 hardness was with the measurement of a minimum of (b)(6) according the specification of 580 (b)(6).Because of the damage, the complaint relevant dimensions cannot be checked for dimensional accuracy of the valid manufacturing specifications.Unfortunately we only have limited information in the complaint description and cannot confirm how this happened.We do suppose that an often and intensive use of drill bits, especially drill bit with lot number 1165595 which was produced in 2003, could have led to complained malfunction.Because of the damage, the complaint relevant dimensions cannot be checked for dimensional accuracy of the valid manufacturing specifications.Also we want to bring up our recommendations within our leaflet, regarding "end of life of an instrument" which describes the: "end of life of a device is normally determined by wear and damage due to use.Evidence of damage and wear on a device may include but is not limited to corrosion (i.E.Rust, pitting), discoloration, excessive scratches, flaking, wear and cracks.Improperly functioning devices, devices with unrecognizable markings, missing or removed (buffed off) part numbers, damaged and excessively worn devices should not be used." finally we conclude that the cause of failure is not due to any manufacturing non-conformances.Unfortunately we only have limited information in the complaint description and cannot confirm how this happened.We do suppose that often and intensive use of drill bits, especially drill bit with lot number 1165595 which was produced in 2003, could have led to complained malfunction.Because of the damage, the complaint relevant dimensions cannot be checked for dimensional accuracy of the valid manufacturing specifications.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: 2.7MM CANNULATED DRILL BIT/QC 2.7MM CANNULATED DRILL BIT/QC
• Type of Device: INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6292997
• MDR Text Key: 66254670
• Report Number: 3000270450-2017-10026
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819018983
• UDI-Public: (01)07611819018983(10)F-16958
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 310.670
• Device Lot Number: F-16958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2017
• Initial Date FDA Received: 02/01/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/03/2017; 06/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1