MAUDE Adverse Event Report: SYNTHES SELZACH TI 12-POINT NUT-11MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 499.294S

Device Problems Material Fragmentation (1261); Dull, Blunt (2407)

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

Event Date 11/08/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown.Additional product codes: mni, mnh, kwp, kwq.Udi: (b)(4)lot unknown.Lot number is either l00514 or l091382, but it is unknown which is the complained lot.L00514 is not a valid lot number, but most like correct potential lot number is l100514.Implant and explant dates: due to intra-operative issues, the device was not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter phone number: (b)(4).A device history record review for both potential lot numbers was completed: manufacturing site: (b)(4).Supplier: (b)(4).Manufacturing date: l100514 ¿ august 23, 2016; l091382 ¿ august 10, 2016.Expiry date: both - august 01, 2026.The devices were initially manufactured in (b)(4) under the unsterile lots l086759 and l074488 respectively and sterilized afterwards.As this complaint is neither packaging nor sterilization related only the documents of the unsterile lots from (b)(4) were reviewed.This review has shown that 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

Device report from synthes (b)(4) reports an event in the (b)(6) as follows: it was reported that when tightening the nut onto the sleeve the nut stripped.This happened twice with two different nuts during the same case.The case was completed successfully.The broken off part was removed and replaced with a new implant.There was no patient impact and the surgery was not prolonged.Concomitant reported part: sleeve (part and lot number unknown, quantity 1).This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Patient age reported as (b)(6).(b)(4).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

The surgery was a paediatric deformity case.Both nuts threads stripped during the same surgery.

• Brand Name: TI 12-POINT NUT-11MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6140159
• MDR Text Key: 61292776
• Report Number: 3000270450-2016-10283
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/08/2016

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 Catalogue Number: 499.294S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/08/2016
• Initial Date FDA Received: 12/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 1 UNKNOWN SLEEVE