MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DLC HEX SCRDRVR SHAFT RIGID; HIP INSTRUMENTS : SCREWDRIVERS

Model Number	2274-04-000
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 the straight screwdrivers are broken.The threads will not thread on screws.Hex is filed down.There were no reported patient consequences or surgical delays.
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 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.
Event or Problem Description
Additional information received indicated that another set was on standby.The amount of time it took to open a wrapped instrument after noticing the other was filed down was about 30 seconds to 1 minute.There was no impact to patient.
Event or Problem Description
With regards to this, please confirm if any of the following information is available: a.Can you please confirm , what part of the instrument broke? b.Did it break into two or more pieces? c.Did the instrument used during surgery? if yes, was surgery time extended? what was the duration of the delay? d.Please verify if there were pieces broken off from the instrument or it just cross-threaded? answer: the instrument was cross threaded and was not broken in two pieces.It was used in surgery and would not thread on the screws.We had backup and opened the backup tray.Very little time was delayed from surgery.No impact to patient.It has been returned/replaced.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.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.H10 additional narrative:  added: b5 and d9 corrected: h3 and h6 (patient).

• Brand Name: DLC HEX SCRDRVR SHAFT RIGID
• Common Device Name: HIP INSTRUMENTS : SCREWDRIVERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11748383
• Report Number: 1818910-2021-09211
• Device Sequence Number: 4417788
• Product Code: HXX
• UDI-Device Identifier: 10603295109037
• UDI-Public: 10603295109037
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/10/2021

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: 2274-04-000
• Device Catalogue Number: 227404000
• Device Lot Number: SO2045155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 04/29/2021; 05/11/2021; 05/11/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 04/29/2021; 05/13/2021; 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1