MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.2MM PERCUTANEOUS DRILL BIT QC/300MM/CALIBRATED; BIT, DRILL

Catalog Number 324.212

Device Problem Failure to Cut (2587)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2019

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.The instrument(s) was not returned, and instead the investigation will be done based on the supplied image(s).The image(s) was reviewed, and the complaint condition could not be confirmed as the image provided does not show any defect with the device, and the functionality cannot be determined.As the instrument(s) was not returned an as received condition, dimensional inspection, material, or drawing reviews are not applicable.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending, and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective, and/or preventative action is proposed.A device history record (dhr) review was conducted: part: 324.212; lot: 50p8623; manufacturing site: (b)(4); release to warehouse date: 21 april 2020.A manufacturing record evaluation was performed for the finished device # 324.212, lot number# 50p8623, and no non-conformances were identified.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 during an unknown surgical procedure on (b)(6) 2020, the little cutting of the three (3) reported drills was evident.Additionally the 3.2 drill bit bends when having to force it to cut.The screwdriver part has a damaged anchor, therefore, it does not couple with the handle.No patient consequences or patient harm reported.This report is for one (1) 3.2mm percutaneous drill bit qc/300mm/calibrated.This is report 3 of 3 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.Investigation flow: damage.Visual inspection: the drill bit ã¿3.2 percut calibr (p/n: 324.212, lot # 50p8623) was returned and received at us cq.Upon visual inspection, the tip of the drill bit is slightly deformed.No other issues were identified with the returned components of the device.Device failure/defect was identified.Functional test: functional test cannot be performed as the device was received by itself.However, the allegation will not cut/dull can be confirmed because the tip of the drill bit looks slightly deformed.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed.The complaint was confirmed.The device received is deformed at the tip.Investigation conclusion the complaint condition is confirmed for the drill bit ã¿3.2 percut calibr (p/n: 324.212, lot # 50p8623).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot part: 324.212, lot: 50p8623, manufacturing site: bettlach, release to warehouse date: april 21, 2020.A manufacturing record evaluation was performed for the finished device # 324.212, lot number# 50p8623, and no non-conformances were identified.,part: 324.212, lot: 50p8623, manufacturing site: bettlach, release to warehouse date: april 21, 2020.A manufacturing record evaluation was performed for the finished device # 324.212, lot number# 50p8623, and no non-conformances were identified.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: 3.2MM PERCUTANEOUS DRILL BIT QC/300MM/CALIBRATED
• Type of Device: BIT, DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10743454
• MDR Text Key: 213930798
• Report Number: 8030965-2020-08235
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07611819915343
• UDI-Public: (01)07611819915343
• 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: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 324.212
• Device Lot Number: 50P8623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 94 YR
• Patient Weight: 50