MAUDE Adverse Event Report: SYNTHES MONUMENT ADJUSTABLE CERVICAL DISTRACTOR-RIGHT; MISC ORTHO SURGICAL INSTR

Catalog Number	396.396
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reportedly there was no patient involvement.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the service history records has been requested.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 or Problem Description
It was reported that an adjustable cervical distractor (right) was found broken.It is unknown when this device broke.It was reported there was no patient involvement.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A service & repair evaluation/review was attempted; no service history review can be performed as part number 396.396 with lot number(s) a7ka51/4361259 is a lot/batch controlled item.The manufacture date of this item is 2-jan-2002.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.Device history records review was conducted.The report indicates that the: dhr review for: manufacturing location: (b)(4), packaged by: (b)(4).Manufacturing date: 02-jan-2002.Part #: 396.396, lot # a7ka51 / synthes lot # 4361259 (non-sterile) - adjustable cervical distractor - right.Quantity 14.No ncrs 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.Subject device has been received and a service & repair evaluation was performed.The investigation of the complaint articles has shown that: the customer reported the item was broken.The repair technician reported the shaft connection was broken.Damaged component is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.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.
Additional Manufacturer Narrative
A product development investigation was performed on the subject device (adjustable cervical distractor-right, part #: 396.396, lot # a7ka51).The returned device is broken at the rotational strut.The rotational strut is broken next to the connection to the joint component.Both of the joint components are also cracked where the dowel pin mates with the component.The device has surface wear which does not impact functionality.A visual inspection, drawing review and device history record (dhr) 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 adjustable cervical distractor ¿ right (396.396) is noted in the syncage-c, cervios and anterior cervical fusion (acf) instruments technique guides.The distractor is one of two pin distractors, the other being 396.395, utilized for intervertebral distraction for anterior cervical applications.In use, distractor pins are inserted into adjacent vertebral bodies and the distractor is loaded over the pins.Lordosis can be adjusted prior to distraction through the use of the angled knob.The drawings were reviewed as part of investigation.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.It is likely that the complaint condition was caused by wear due to continued use of the device over 15 years.There were no issues during the manufacture of this product that would contribute to this complaint condition.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: ADJUSTABLE CERVICAL DISTRACTOR-RIGHT
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6222870
• Report Number: 1719045-2017-10003
• Device Sequence Number: 376845
• Product Code: LXH
• UDI-Device Identifier: 10705034777528
• UDI-Public: (01)10705034777528(10)A7KA51
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2016

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
• Operator of Device: Health Professional
• Device Catalogue Number: 396.396
• Device Lot Number: A7KA51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/12/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/04/2017
• Supplement Report FDA Received Date: 01/25/2017; 02/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1