MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 4.0MM FEMALE HEX DRIVER; EXTREMITY INSTRUMENTS : SCREWDRIVERS

Model Number	2100-70-155
Medical Device Problem Codes	Crack (1135); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the scrub tech was assembling trial proximal body to stem when the tip of 3.5 male hex driver slipped off the assembly nut.It was noticed that the tip of the driver was cracked.Another 3.5 male hex nut drive was opened and assembly was done.No delay was there.Received additional information through email from (b)(6) on (b)(6) 2022 stating: a)there were no separate pieces, and b) i provided the wrong part number.It should have been 2100-70-155 4.0 female hex screwdriver.Wrong part number is listed on the shoulder xpert app on the revision tray.The lot number is correct for this catalog number.
Additional Manufacturer Narrative
Product complaint # (b)(4).No device associated with this report was received for examination.The investigation could not verify or draw any conclusions about the root cause of the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.No device associated with this report was received for examination.The investigation could not verify or draw any conclusions about the root cause of the reported event without the device to examine.The investigation could not verify or identify any product contribution to the current reported event without the device to examine.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.Based on the inability to confirm the reported event or draw any conclusions about root cause, the need for corrective action was not indicated.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.Depuy 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.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.

• Brand Name: 4.0MM FEMALE HEX DRIVER
• Common Device Name: EXTREMITY INSTRUMENTS : 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 46580 ; 3035526892
• MDR Report Key: 16052098
• Report Number: 1818910-2022-26072
• Device Sequence Number: 15039455
• Product Code: HXX
• UDI-Device Identifier: 10603295085959
• UDI-Public: 10603295085959
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/27/2022

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: 2100-70-155
• Device Catalogue Number: 210070155
• Device Lot Number: PG217691
• 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: 12/13/2022
• Initial Report FDA Received Date: 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2012
• 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: Female