MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET 1PC FLEX DRILL BIT 25; DRILLS

Catalog Number 227425500

Device Problems Break (1069); Crack (1135); Material Deformation (2976); Naturally Worn (2988); Illegible Information (4050)

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

Event Date 01/24/2024

Event Type  malfunction  

Manufacturer Narrative

Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during a total hip replacement, the 25mm flexible drill bit broke.It did not break completely in half.This did not delay the procedure and another drill but was used without any further issues.

Event Description

Additional information was received stating that there was a slight delay while a different drill bit was loaded but that did not take even a minute.Unfortunately, the lot number had worn off the drill bit and was unable to be read.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint: (b)(4).Investigation summary: according to the information received, "during a total hip replacement, the 25mm flexible drill bit broke.It did not break completely in half." the product was not returned to depuy synthes, however photos were provided for review.See attachment (img_5394).The photo investigation revealed that the device 227425500, quickset 1pc flex drill bit 25 was bent and broken from the flexible shaft.The observed damage can be attributed to unintended use error due to overload of the flexible shaft.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the 227425500, quickset 1pc flex drill bit 25 would contribute to the complained device issue.Based on the investigation findings, the potential cause can be traced to unintended use error and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: according to the information received, "during a total hip replacement, the 25mm flexible drill bit broke.It did not break completely in half." the product was not returned to depuy synthes, however photos were provided for review.See attachment (img_5394).The photo investigation revealed that the device 227425500, quickset 1pc flex drill bit 25 was bent, broken from the flexible shaft, etch was not clear to read and crack cannot be confirmed from the provided evidence.The observed damage can be attributed to unintended use error due to overload of the flexible shaft.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the 227425500, quickset 1pc flex drill bit 25 would contribute to the complained device issue.Based on the investigation findings, the potential cause can be traced to unintended use error and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: QUICKSET 1PC FLEX DRILL BIT 25
• Type of Device: DRILLS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18605374
• MDR Text Key: 334089428
• Report Number: 1818910-2024-01984
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 10603295109129
• UDI-Public: 10603295109129
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 227425500
• Device Lot Number: PG319589
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2022
• 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