MAUDE Adverse Event Report: SYNTHES HAGENDORF 2.7MM CANNULATED DRILL BIT/QC 160MM; 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 Date 01/05/2017

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional device product codes are gfa, gff and hsz.Device is an instrument and is not implanted/explanted.The subject device is not expected to be returned to the synthes manufacturer for evaluation.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review was performed for the subject device lot.Manufacturing location: synthes (b)(4).Date of manufacture: apr 14, 2003.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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.There was no prolongation of the surgery was reported and the patient outcome was good.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: 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

It was reported that upon the return of the surgery box to the stock point, it was noted that one more device was worn out.This is report 1 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 587 hv and 593 hv according the specification of 580 /+60 hv.For lot 1165595 hardness was with the measurement of a minimum of 594.4 hv and 604.4hv according the specification of 580 /+60 hv.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 160MM
• Type of Device: INSTR, SURGICAL, ORTHOPEDIC, AC- POWERED MOTOR/ACCESS & ATTACH
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6292226
• MDR Text Key: 66495163
• Report Number: 3003875359-2017-10045
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819018983
• UDI-Public: (01)07611819018983(10)1165595
• 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,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: 1165595
• 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: 01/05/2017
• Initial Date FDA Received: 02/01/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/01/2017; 04/03/2017; 06/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2003
• 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