MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM; BIT, DRILL

Catalog Number 323.062

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history records has been requested.Device was used for treatment, not diagnosis.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, during an unknown procedure with variable angle-locking compression plate (va-lcp) distal humerus plate, two (2) drill bits were reported as blunt.The surgery was completed successfully although it was not reported how the surgery was finished.There was no surgical delay.There was no adverse consequence to the patient.Concomitant devices reported: va-lcp distal humerus plate (part #: unknown, lot #: unknown, quantity: 1) and unknown screw (part #: unknown, lot #: unknown, quantity: 1).This complaint involves two (2) devices.This report is 2 of 2 for (b)(4).

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.A device history record (dhr) review was conducted.Part: 323.062 , lot: l945891, manufacturing site: bettlach , release to warehouse date: 19.Jul.2018.The device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional 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 conducted.Visual inspection: the received drill bits are in a used condition.The tips and as well the cutting edges are worn.Dimensional inspection: because of the damages the complaint relevant dimensions cannot be checked to print specifications anymore.Drawing/specification review: the manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.Failure in material or production could not be detected.Summary: due the visible damages on the drill bits the complaint condition is rated as confirmed.However, based on the provided information we are not able to determine the exact cause of this complaint.We only can assume that a mechanical overloading situation, metallic contact or simply regular wear could lead to the visible damages.In this regard, we would like to draw your attention on page 4 in the leaflet ¿important information¿: 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 manufacturing investigation results we conclude that the cause of failure is not due to any manufacturing non-conformances.It has been determined that no corrective and/or preventative action is proposed.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: 2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM
• Type of Device: BIT, DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8157679
• MDR Text Key: 130177068
• Report Number: 8030965-2018-58971
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07611819166264
• UDI-Public: (01)07611819166264
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 323.062
• Device Lot Number: L945891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Date Manufacturer Received: 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1