MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. SIG HP FBT CEM KL PNCH SZ4-5; KNEE INSTRUMENT/TRIAL

Catalog Number 950502048

Device Problem Disassembly (1168)

Patient Problem No Information (3190)

Event Date 02/23/2016

Event Type  malfunction  

Manufacturer Narrative

Qty (b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

After impacting the punch, the handle releases from the punch by hitting back the punch.Then its difficult to remove the punch out of the tibia.

Manufacturer Narrative

Additional narrative: conclusion and justification status for mdr: the device associated with this report was not returned.The product lot code was not provided.A search of the complaint database against the reported product code found additional reports of assembly/disassembly problems.Prior investigations were identified for further in-depth analysis to assist in the determination of the root cause.A saw bone evaluation determined debris entrapped in the keel punch slot can contribute to the punch impactor failing to engage with the keel punch.The investigation could not verify or identify any product contribution to the current reported event with the information provided.Based on the inability to determine a root cause, a need for corrective action is not indicated.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.

Manufacturer Narrative

(b)(4).The investigation has been reopened due to receiving product for evaluation.Depuy will notify the fda when the investigation is complete.

Manufacturer Narrative

Conclusion and justification status for mdr: functional evaluation of (4) of the submitted sigma hp fbt keel punch impactors with the retuned hp fbt keel punches could not replicate the reported mating issue.Although a surgical environment could not be created for testing purposes, the punch impactor mated and disassembled from the keel punch with no restrictions or difficulties.The investigation could not draw any conclusions about the root cause of the complainant's assembly problems; however, the instruments exhibit evidence of normal use and serving which could be a contributing factor.No evidence was found indicating product error was a contributing factor and no corrective action is being pursued.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.

• Brand Name: SIG HP FBT CEM KL PNCH SZ4-5
• Type of Device: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5488413
• MDR Text Key: 39930498
• Report Number: 1818910-2016-14884
• Device Sequence Number: 1
• Product Code: LRY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 950502048
• Device Lot Number: J0509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1