MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA SUBTALAR MBA IMPLANT, 12MM; N/A

Catalog Number 050112

Device Problems Device Expiration Issue (1216); Shelf Life Exceeded (1567)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Type  Injury  

Event Description

It was reported the device was used for a procedure.It is implied the device was used beyond the expiry date.The date of the procedure/implantation has not been provided.Additional information has been requested.

Manufacturer Narrative

Additional information received 31aug2016: the sales representative for this case worked for the distributor, not integra.The integra regional sales manager provided instruction and permission to sterilize the product out of the package.There will be no revision surgery nor removal of the implant.Integra has completed their internal investigation on 23sep2015.The additional investigation activities included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: a review of the device history record (dhr) for p/n 050112 revealed that (b)(4) sterile mba implants were sent to special team medical services under work order (b)(4) to be re-packaged and re-sterilized.Work order (b)(4) identified the implants as coming from supplier lot # gt0103.The re-sterilized implants were returned to ils (b)(4) on december 7, 2010, inspected (n = 8) and released into finished goods inventory on december 9, 2010.There were no mrrs or variances associated with this product lot.Based on existing procedures at that time, the lot code printed on the product label was 088946, for traceability to the work order.A query was performed to identify other complaints associated with expired implants that were sent to, or used by a hospital.The query was limited to orthopedic, tissue and technologies (ott) reconstructive implants and covered the past 24 months.The query identified four additional complaints.Including this complaint, integra has received and confirmed a total of five complaints over the past 24 months in which a non-sterile orthopedic device has been implanted.A failure analysis, based on the number of sold devices, wasn¿t calculated but a review of the ils (b)(4) decontamination records revealed that (b)(4) katalyst, kompressor, mba, freedom wrist, universal2, titanium bone wedge, salto talaris ankle, cadence ankle, reverse shoulder and panta instrument sets have been returned and processed over the past 24 months.All of these sets require individually packaged and sterilized implants.The total number of customer complaints versus the number of opportunities is well below the threshold established in product risk management for requiring corrective action.Conclusion: based on the information that was provided from the complainant, integra was able to confirm that expired product was provided by a distributor to a hospital.Hospital personnel decided to re-sterilize the implant based on instructions provided by integra.The root cause for this complaint was a breakdown in the inspection process of existing inventory by the distributor.

• Brand Name: SUBTALAR MBA IMPLANT, 12MM
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5896062
• MDR Text Key: 52746773
• Report Number: 3004608878-2016-00221
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: K960692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Catalogue Number: 050112
• Device Lot Number: 088946
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other