MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC PEEK INTERFERENCE SCREWS 5 X 15MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 86PS0515

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/17/2022

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

It was reported that the implant was not in the box.It appeared as that the implant had been used at a previous hospital and the scrub nurse had returned the empty box to the black/yellow shipper.Because the implant the surgeon wanted wasn¿t available he decided he had to drill a size bigger so he could use the 6mmx20mm g-force screw as he wasn¿t happy using the other size 5mm option of screw which was the 5mmx10mm screw due to the lack of length.A surgical delay of 3 minutes was reported.

Event Description

It was reported that the implant was not in the box.It appeared as that the implant had been used at a previous hospital and the scrub nurse had returned the empty box to the black/yellow shipper.Because the implant the surgeon wanted wasn¿t available he decided he had to drill a size bigger so he could use the 6mmx20mm g-force screw as he wasn¿t happy using the other size 5mm option of screw which was the 5mmx10mm screw due to the lack of length.A surgical delay of 3 minutes was reported.

Manufacturer Narrative

The reported event could be confirmed due to the information provided.Based on investigation, the root cause was attributed to a transport/storage related issue.The failure was caused by inadequate manual inspection of the product packaging.It appears the product was used previously and a manual check of the product packaging had not been undertaken fully.A review of the device history for the reported lot did not indicate any abnormalities.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.A local nc was created to further investigate the issue.

• Brand Name: PEEK INTERFERENCE SCREWS 5 X 15MM
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15779383
• MDR Text Key: 303702115
• Report Number: 3010667733-2022-00382
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K083150
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 86PS0515
• Device Catalogue Number: 86PS0515
• Device Lot Number: 1715570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1