MAUDE Adverse Event Report: SYNTHES MEZZOVICO TI OCCIPITAL PLATE/ROD; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number 04.161.030

Device Problem Fracture (1260)

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

Event Date 01/18/2017

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.The subject device has been received and is currently undergoing investigation.A device history record review of the subject device will be requested.Date of manufacture is unknown at this time.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 an unspecified surgical procedure on (b)(6) 2017 the surgeon was bending the occipital plate/rod during and noticed that it had fractured at a screw hole during bending.There was no patient harm or surgical delay reported.This report is 1 of 1 for com-(b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Date received by mfr was inadvertently reported as february 27, 2017.Date should be february 15, 2017.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.A device history record review was performed for the subject device lot.Manufacturing location: (b)(4); manufacturing date: 05.Feb.2009.No non-conformances 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.A product development investigation was performed for the subject device.The returned occipital plate/rod was confirmed to be broken.Two of the four holes in the plate section are missing and the fragment was not returned.The first hole in the plate section is cracked and there are gouges in the plate which appear to be from the bending pliers.There is some brown discoloration across much of the device.A visual inspection and drawing review were performed as part of this investigation.The complaint is confirmed.Replication of the complaint condition is not applicable as the device is already broken.The returned implant is part of the occipital cervical fusion instrument and titanium implant set.The following drawings were reviewed during investigation.Ti occipital plate/rod - 04_161_030: the design history was not found to impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.No definitive root cause was able to be determined.The breakage is potentially related to rough handling during bending, as the plate is cracked and gouged in addition to being broken.The cause of the discoloration unknown as the conditions for storage/sterilization are not known.There were no issues during the manufacture of this product that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

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

Concomitant device reported: hand held rod bender (french bender) (part #2883-05-400, lot#: unknown, quantity 1).

• Brand Name: TI OCCIPITAL PLATE/ROD
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CO CH680 5; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CO CH680 5; SZ CH6805
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6327551
• MDR Text Key: 67334596
• Report Number: 1719045-2017-10096
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 10705034733494
• UDI-Public: (01)10705034733494(10)3080348
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.161.030
• Device Lot Number: 3080348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1