MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 17.8MM DRILL BIT LARGE QC/312MM; BIT,DRILL

Catalog Number 309.600

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(510k): device is not distributed in the united states, but is similar to device marketed in the usa.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 reports an event in (b)(6) as follows: it was reported that on unknown date, the shaft at the proximal end of the drill bit broke off.It is unknown if there were procedure and patient involvement.This report is for one (1) 17.8mm drill bit.This is report 1 of 1 for complaint (b)(4).

Event Description

It was reported that on an unknown date during an open reduction of proximal femoral fracture with three (3) cable cerclage and a long proximal femoral nail antirotation (pfna) for a right subtrochanteric femoral fracture, the shaft at the proximal end of the drill bit broke off.There was a twenty (20) minute surgical delay reported.Reportedly there was no impact to the patient; the patient status was good.Surgical outcome was unknown.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Part 309.600, lot 2157496: manufacturing site: selzach.Supplier: sphinx werkzeuge ag.Release to warehouse date: february 27, 2006.The device history record shows this lot of devices was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.A product investigation was completed: the visual inspection has shown that the drill bit shaft is broken close to the quick coupling.The broken part was not returned.The cutting edges of the drill bit are in a very poor condition.The relevant features are heavy damaged in a manner which prevents accurate measurement of the features.The visual inspection has shown that the drill bit shaft is broken close to the quick coupling.Therefore, this complaint is rated as confirmed.Unfortunately we are not able to determine the exact cause of this complaint.The cutting edges of the drill bit are in a very poor condition.The broken surface is homogenous what indicates material conformity to the specification as well.Based on the provided information we are not able to determine the exact cause of this complaint.The wear and tear indicate that the product was often and intensive used instrument.It is likely that the cause of the breakage is the result of a mechanical overload situation during use.The bad condition of the device, before surgery, may also have played certain role to the complained issue.The product literature states: ¿check instruments for sound surfaces, and correct adjustment and function.Do not use severely damaged instruments, instruments with unrecognizable markings, corrosion, or blunt cutting surfaces.¿ based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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: 17.8MM DRILL BIT LARGE QC/312MM
• Type of Device: BIT,DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8127186
• MDR Text Key: 129153366
• Report Number: 8030965-2018-58718
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07611819292895
• UDI-Public: (01)07611819292895
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/16/2018

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: 309.600
• Device Lot Number: 2157496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Initial Date Manufacturer Received: 11/16/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 12/18/2018
• Supplement Dates FDA Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR