MAUDE Adverse Event Report: SYNTHES SELZACH BIOPSY KIT 10G-STERILE; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Catalog Number 03.804.522S

Device Problem Device Expiration Issue (1216)

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

Event Date 04/22/2016

Event Type  malfunction  

Manufacturer Narrative

Patient weight is unknown.(b)(4).Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: (b)(4).Supplier: (b)(4).Manufacturing date: february 26, 2014.Expiry date: february 01, 2016.No anomalies were detected during device history record review.No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that during the procedure on (b)(6) 2016 of kyphoplasty bilateral surgery for t12 fracture, the biopsy kit was noticed to be expired.The expired kit was used during the procedure.There were no abnormalities in appearance or function when the kit was used.It was reported that the kit expired in february 2016.No adverse events were reported, procedure was successfully completed and no surgical delays were reported.Patient was not exposed to additional anesthesia time as a result of the event.(b)(4).

• Brand Name: BIOPSY KIT 10G-STERILE
• Type of Device: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5644198
• MDR Text Key: 45225102
• Report Number: 3000270450-2016-10117
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2016
• Device Catalogue Number: 03.804.522S
• Device Lot Number: 14B14-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 61 YR