MAUDE Adverse Event Report: SYNTHES MONUMENT POLYAXIAL HEAD PLACEMENT TOOL FOR MATRIX; MISC ORTHO SURGICAL INSTR

Catalog Number 03.632.037

Device Problems Disconnection (1171); Device Dislodged or Dislocated (2923)

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

Event Date 04/19/2016

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted or explanted.(b)(6).Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.A review of the device history records has been requested and is currently pending completion.Device 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 from (b)(6) as follows: it was reported that a patient underwent a surgical procedure on (b)(6) 2016.During 3d-head insertion into the bone screw, the inner portion of the polyaxial head placement tool dropped.The part was easily removed from the patient.The procedure was completed with no reports of surgical delay or patient harm.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Part 03.632.037, lot 7480168: manufacturing location: supplier- (b)(4).Manufacturing date: march 11, 2016.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.(b)(6).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 confirmed that no piece of the instrument remained in the patient.The fragments were easily removed; no medical intervention was needed.The procedure was completed successfully.

Manufacturer Narrative

A product investigation was completed: the returned positioning instrument for polyaxial screw heads was examined and the complaint condition was able to be confirmed as the distal blocker was found to be missing.Evidence of laser welding was apparent on the distal portion of the outer shaft body.The blocker is only laser welded to half of the outer shaft body, making it vulnerable to breakage in the area of the laser weld.No definitive root cause was able to be determined however the failure mode is consistent with rough handling.Per the technique guide, the polyaxial head placement tool (03.632.037) is used in the matrix degenerative and deformity spine systems.The tool is used to retrieve a polyaxial head from an implant module and place it over a matrix bone screw.The technique guides state that, to ensure the polyaxial head is securely attached to the bone screw, the user is to gently lift up on the placement tool and angulate the polyaxial head.Relevant drawings for the returned instrument were reviewed (both current revision and from the time of manufacture): top-level, outer shaft w/ overmold and blocker.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.A device history review was performed for the returned instrument¿s lot number and no material review reports, non-conformance reports or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is confirmed.No definitive root cause was able to be determined however the failure mode is consistent with rough handling.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.

• Brand Name: POLYAXIAL HEAD PLACEMENT TOOL FOR MATRIX
• Type of Device: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5663838
• MDR Text Key: 45432916
• Report Number: 1719045-2016-10414
• Device Sequence Number: 1
• Product Code: LXH
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2016

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: 03.632.037
• Device Lot Number: 9984411
• Other Device ID Number: (01)07611819379442(10)9984411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2016
• Initial Date FDA Received: 05/18/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/09/2016; 06/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 33 YR