MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI COLLAR FOR 6.0MM RODS FOR USS DUAL-OPENING; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 499.302S

Device Problems Break (1069); Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: device is not distributed in the united states, but is similar to device marketed in the usa.Sterile part 499.302s, lot 6l49339: manufacturing site: (b)(4).Supplier: (b)(4) release to warehouse date: december 05, 2019.Expiry date: november 01, 2029.Non-sterile part 499.302, lot 6l06717: manufacturing site:(b)(4).Release to warehouse date: september 09, 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.A product investigation was completed: photo review: complaint is confirmed as we are able to confirm the device is broken based on the received pictures.The physical product was also received.Returned item has not been received in original packaging.Item is broken postproduction at level of the threaded slot.No evidence of visual nonconformance manufacturing related.The returned part was re-inspected for all the features relevant to the complaint condition.The measurable features have been found conforming to manufacturing specifications.No nonconformances or document change have been identified which may be related to the complaint condition.The investigations performed didn't identify any manufacturing defect or deficiency, thus the complaint investigation is considered as not manufacturing related.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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)(6) reports an event as follows: it was reported that during final tightening of the nuts during a universal spine system (uss) procedure, the sleeve on the left hook t3 failed.The surgeon had placed two rods and all the corresponding sleeves and nuts.The broken sleeve was removed and replaced with a new sleeve.The procedure was successfully completed with about a three (3) minute delay.Concomitant devices reported: uss rods (part unknown, lot unknown, quantity 2); uss screws (part unknown, lot unknown, quantity unknown); uss-ii nuts (part unknown, lot unknown, quantity unknown); polyaxial head (part unknown, lot unknown, quantity unknown) this report is for an uss-ii sleeve.This is report 1 of 1 for (b)(4).

• Brand Name: TI COLLAR FOR 6.0MM RODS FOR USS DUAL-OPENING
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 9829995
• MDR Text Key: 188259926
• Report Number: 8030965-2020-01910
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07611819967311
• UDI-Public: (01)07611819967311
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 499.302S
• Device Lot Number: 6L49339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1