MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET TPRD HEX SCDR CARDAN; SCREWDRIVERS

Catalog Number	227449000
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	12/20/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that upon placing the screw into the cup with the screwdriver, the screw is seated, but the screwdriver was locked into the hex top of the screw.After trying to slap it out, 1/2 of the hex bit snapped and was left in the screw.This hindered the flat surface of the cup, which would hinder liner impaction.The doctor tried to remove the bit of screw with osteotome, vice grip, needle driver, rongeour and kocher.It was tried for 15 minutes to remove this.Eventually a metal cutting bur was used to bur the surface so it could suitably seat the liner.The liner was impacted after 20 minutes of dealing with this broken screw, and checked stability.It was 100%.There was a surgical delay of 20mins.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received: it was reported that upon placing the screw into the cup with the screwdriver, the screw is seated, but the screwdriver was locked into the hex top of the screw.After trying to slap it out, 1/2 of the hex bit snapped and was left in the screw.This hindered the flat surface of the cup, which would hinder liner impaction.The doctor tried to remove the bit of screw with osteotome, vice grip, needle driver, rongeour and kocher.It was tried for 15 minutes to remove this.Eventually a metal cutting bur was used to bur the surface so it could suitably seat the liner.The liner was impacted after 20 minutes of dealing with this broken screw, and checked stability.It was 100%.There was a surgical delay of 20mins.The product was not returned to depuy synthes, however photos were provided for review.See attachment (21_dec_2023_06_54_23_13916.Eml, 21_dec_2023_06_53_47_17102.Eml).The photo investigation found that the evidence attached doesn't show the broken portion of the quickset tprd hex scdr cardan associated with this complaint and shows another device as reference.Only the hudson adaptor portion is shown in photo evidence.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the quickset tprd hex scdr cardan would not contribute to the complained device issue.Based on the investigation findings, 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 device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: QUICKSET TPRD HEX SCDR CARDAN
• Common Device Name: SCREWDRIVERS
• 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: 18443339
• Report Number: 1818910-2024-00320
• Device Sequence Number: 20537615
• Product Code: HXX
• UDI-Device Identifier: 10603295109259
• UDI-Public: 10603295109259
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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
• Operator of Device: Health Professional
• Device Catalogue Number: 227449000
• Device Lot Number: SO2063038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2023
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown