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

Catalog Number 323.062

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Photo investigation summary: the complaint device (drill bit ø2 w/double marking l140/115 3 p.Code: 323.062 lot#: unk) was not received for investigation.A photo investigation was performed based on the photos provided".Reviewing the evidence provided the reported event can be confirmed.After review of the photo provided it can be visually detected that the device tip is broken and cracked.Broken portion is not shown on the picture.No other issues were found during the review of the evidence.A definite assignable root cause could not be determined based on the provided information.A manufacturing record evaluation cannot be performed due to lack of lot number.As the device was not returned, and as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.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.The device lot number is unknown, therefore a device history review could not be performed.If more information become available, the record will be re-assessed 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 depuy synthes reports an event in (b)(6) as follows: it was reported that during a procedure, a 2.0mm drill bit off the va elbow loan set was chipped.No fragments were generated.There were 2 of these drill bits on the set so the case was not compromised.The procedure was successfully completed without any surgical delay.No patient consequences reported.This report is for one (1) 2.0mm drill bit with depth mark/qc/140mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM
• Type of Device: BIT, DRILL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13735863
• MDR Text Key: 290071809
• Report Number: 8030965-2022-01551
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07611819166264
• UDI-Public: (01)07611819166264
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 323.062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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