MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM MILLER SHELL SZ 21; HIP INSTRUMENTS : INSERTION DEVICES

Model Number	2576-05-021
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that during a case the screws from an srom instrument came off which caused the instrument to slide and make difficult to remove.We also noticed a milling device (we didn't use it but noticed it) has many metal fragments on it and the milling and noticeable burrs out of it as well.
Event or Problem Description
Additional information received indicated that the instrument breaking in two pieces is inaccurate.The screws on the top of the device came out (3 screws total, 2 came out), both were found but not available during the time of packing up the instruments.
Additional 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.Corrected: h6 (the device code break is removed and updated to detachment of device or device component).
Additional 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.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the device associated with this complaint was returned for examination.The visual examination of the device and photo evidence found two device screws, that hold the washers, broken and deep nicks and scratches that show signs of interaction with another device on the washers and close to the washers.Fell apart reported condition was not confirmed, as the screws broke off.The device condition would make it hard to remove.However, since the device was returned without a mating device assembled, the unable to disassemble condition could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Drawing/specifications reviewed: drawing: n/a.Specification review was not performed since it was not applicable to the complaint condition.Dimensional inspection: a dimensional inspection was not performed since it was not applicable to the complaint condition.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.Corrected: h3.

• Brand Name: SROM MILLER SHELL SZ 21
• Common Device Name: HIP INSTRUMENTS : INSERTION DEVICES
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15103889
• Report Number: 1818910-2022-14057
• Device Sequence Number: 5255010
• Product Code: HWT
• UDI-Device Identifier: 10603295145547
• UDI-Public: 10603295145547
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/26/2022

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 Model Number: 2576-05-021
• Device Catalogue Number: 257605021
• Device Lot Number: AG0408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 07/27/2022; 08/18/2022; 10/11/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 08/02/2022; 08/22/2022; 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2008
• 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