MAUDE Adverse Event Report: CODMAN & SHURTLEFF INC. SURG PAT XRAY 1/2X1 -200; SURGICAL PATTIES

Catalog Number 801402

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported the tantal markings of the patties were not visible under brilliance amplifier.Product was in contact with the patient; however no patient injury reported and the event led to 1 hour surgical delay.The patties were used on an anterior lumbar arthrodesis procedure.

Manufacturer Narrative

Updated fields: d4, d10, g4, g7, h2, h3, h4, h6, h10.Device identifier (b)(4).The patties were not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Manufacturer Narrative

Dhr: there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Product was returned for evaluation, and the following was performed on the returned unit: the pattie/strip unit was inspected using x-ray machine in the research and development lab.The sample was tested at 80kv and was visible under the x-ray.The complaint could not be confirmed.In the failure analysis that was performed, the returned unit was found to work as intended, and met all acceptance criteria.The complaint could not be verified through failure analysis.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.

Event Description

N/a.

• Brand Name: SURG PAT XRAY 1/2X1 -200
• Type of Device: SURGICAL PATTIES
• Manufacturer (Section D): CODMAN & SHURTLEFF INC.; 325 paramount drive; 325 paramount drive; raynham NJ 02767
• MDR Report Key: 10399943
• MDR Text Key: 206579685
• Report Number: 3014334038-2020-00020
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• PMA/PMN Number: K880402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 801402
• Device Lot Number: HP1034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/12/2020
• Supplement Dates Manufacturer Received: 09/02/2020; 03/19/2021
• Supplement Dates FDA Received: 09/16/2020; 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR