MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PW PIN PULLER; KNEE INSTRUMENT : EXTRACTION INSTRUMENTS

Model Number	96-6515
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
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
Pin puller has become sprung and pins are able to be pulled but the pin becomes stuck in the instrument.Not detrimental to patient just inconvenience to customers utilizing instrument.
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.H10 additional narrative: added: e1 facility name if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: b3, h6 (medical device problem code).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with the reported event was not returned for evaluation.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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 lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: PW PIN PULLER
• Common Device Name: KNEE INSTRUMENT : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10936578
• Report Number: 1818910-2020-25970
• Device Sequence Number: 10938350
• Product Code: HWB
• UDI-Device Identifier: 10603295248637
• UDI-Public: 10603295248637
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 11/16/2020

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: 96-6515
• Device Catalogue Number: 966515
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 11/16/2020; 01/05/2021
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 12/06/2020; 01/06/2021
• Patient Sequence Number: 1