MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG HP FBT CEM KL PNCH SZ1.5-3; KNEE INSTRUMENT : TIBIAL KEEL PUNCH/BULLET

Model Number	9505-02-047
Medical Device Problem Codes	Entrapment of Device (1212); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/01/2020
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
It was reported that the handle did not stay attached to the punch resulting it remains stuck in the bone.
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 added: d10 corrected: h3.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device was unable to replicate the reported event.The investigation found no evidence of product malfunction or product error and the need for corrective action was not established.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.H10 additional narrative: corrected: h3.

• Brand Name: SIG HP FBT CEM KL PNCH SZ1.5-3
• Common Device Name: KNEE INSTRUMENT : TIBIAL KEEL PUNCH/BULLET
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10222576
• Report Number: 1818910-2020-14894
• Device Sequence Number: 14094598
• Product Code: LRY
• UDI-Device Identifier: 10603295227632
• UDI-Public: 10603295227632
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/22/2020

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: 9505-02-047
• Device Catalogue Number: 950502047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 07/01/2020; 07/27/2020
• Initial Report FDA Received Date: 07/02/2020
• Supplement Report FDA Received Date: 07/07/2020; 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1