MAUDE Adverse Event Report: DEPUY RAYNHAM-REG. # 1219655 PFC SIGMA FEM POST AUG SZ4 4MM; KNEE INSTRUMENTS

Catalog Number 960886

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2016

Event Type  Injury  

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.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

A piece of the instrument was left in the patient.

Manufacturer Narrative

The device associated with this report was not returned.Requests for additional investigational inputs were made in accordance with (b)(4) appendix a.Radiographs/x-ray films and implant insertion op notes were requested.No additional information was obtained.A complaint database search finds no additional reports against the provided product and lot combination.The investigation could not verify or identify any product contribution to the 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A product investigation was previous performed under (b)(4).No additional information can be found that would draw an alternative conclusion to the investigations performed on legacy complaints (b)(4).Therefore, no further investigation is necessary.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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 product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: PFC SIGMA FEM POST AUG SZ4 4MM
• Type of Device: KNEE INSTRUMENTS
• Manufacturer (Section D): DEPUY RAYNHAM-REG. # 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY RAYNHAM-REG. # 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6109443
• MDR Text Key: 60180365
• Report Number: 1818910-2016-31653
• Device Sequence Number: 1
• Product Code: NJL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 960886
• Device Lot Number: 614943
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2015
• 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
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 116 KG