MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 PINN CER INSERTER 56MM GRIPPER; EXTRACTION INSTRUMENTS

Model Number	2218-10-056
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (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
This actually broke and they threw it away! so i don¿t have the lot number, it isn¿t available for return, it happened during the case, there was no delay to the case as they opened up a second tray, it was reported on saturday 14th august, apparently one of the attachments snapped off whilst trying to assemble the instrument.
Additional Manufacturer Narrative
Product complaint # = > (b)(4) investigation summary = > no device was received for examination, therefore the reported event 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.Device history lot = > a manufacturing record evaluation (mre) was not possible because the required lot code was not provided.

• Brand Name: PINN CER INSERTER 56MM GRIPPER
• Common Device Name: EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12410999
• Report Number: 1818910-2021-19145
• Device Sequence Number: 5003339
• Product Code: HWB
• UDI-Device Identifier: 10603295457237
• UDI-Public: 10603295457237
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2021

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: 2218-10-056
• Device Catalogue Number: 221810056
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1