MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 4.0MM FEMALE HEX DRIVER; EXTREMITY INSTRUMENTS : SCREWDRIVERS

Model Number	2100-70-155
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/09/2021
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 patient had a revision surgery plan to convert a global unite proximal body to an epiphysis for a reverse shoulder arthroplasty.Surgeon was unable to "unscrew" the proximal body from the stem.The stem/body construct was implanted in the patient.The surgeon ended up removing the entire stem/body construct.Two hex screwdrivers were broken trying to remove screw.A surgical delay of 30 minutes was also reported.Doi: unknown, dor: (b)(6) 2021, right shoulder.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary : examination of the returned device revealed the drive feature was cracked; not broken.The noted damage is consistent use of excessive force during the assembly of the two devices and the investigation did not establish a need for corrective action.Depuy considers the investigation closed.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).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.
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.

• Brand Name: 4.0MM FEMALE HEX DRIVER
• Common Device Name: EXTREMITY INSTRUMENTS : SCREWDRIVERS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12065516
• Report Number: 1818910-2021-13566
• Device Sequence Number: 19861177
• Product Code: HXX
• UDI-Device Identifier: 10603295085959
• UDI-Public: 10603295085959
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 06/09/2021

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: 2100-70-155
• Device Catalogue Number: 210070155
• Device Lot Number: PG238626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 06/23/2021; 08/02/2021
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 07/07/2021; 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR