MAUDE Adverse Event Report: SYNTHES GMBH 2.8MM PERCUTANEOUS DRILL BIT F/LCP® PL QC/200MM/100MM CALIB; BIT, DRILL

Model Number 324.214

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

Event Description

Device report from colombia reports an event as follows: it was reported that on an unknown date, the drill bit arrived with red tape due to a quality defect.This report is for a 2.8mm percutaneous drill bit f/lcp® pl qc/200mm/100mm calib.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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: 2.8MM PERCUTANEOUS DRILL BIT F/LCP® PL QC/200MM/100MM CALIB
• Type of Device: BIT, DRILL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH; muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 15012754
• MDR Text Key: 301941911
• Report Number: 8030965-2022-04829
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 10886982191281
• UDI-Public: (01)10886982191281
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 324.214
• Device Catalogue Number: 324.214
• Device Lot Number: 275P353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2022
• Initial Date FDA Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2021
• 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