MAUDE Adverse Event Report: SYNTHES TUTTLINGEN ADJUSTABLE CERVICAL DISTRACTOR-LEFT; MISC ORTHO SURGICAL INSTRUMENT

Catalog Number	396.395
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no reported patient involvement associated with the complained event.Additional device product code is hwc.Device is an instrument and is not implanted/explanted.The subject device has been received and is currently in the evaluation process.A service and repair history record review has been requested.The results of the review are pending completion.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 during a routine inspection it was discovered that one of the arms of the adjustable cervical distractor-left is broken off.The instrument was found in a repair bin with no other information.There was no report of known patient or procedural involvement associated with the reported event.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
No service history review can be performed as part number 396.395 with lot number(s) t939595 is a lot/batch controlled item.The manufacture date of this item is 17-sep-2009.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.Device history records review was completed for part# 396.395, lot# t939595.Manufacturing location: (b)(4), manufacturing date: sep 15, 2009.No non conformance reports were generated during production.Review of the device history record of (b)(4) showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.A review of inspection records and certifications, confirm that the components and final product met inspection records.All 16 parts of the lot were checked 100% for important features and for function at the final inspection on 14-sep-2009.Service and repair evaluation was completed.The customer reported the one of the arms was broken.The repair technician reported the hinge broke in two pieces.Hinge broken 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.Product development investigation was completed.A visual inspection, drawing review and dhr review were performed as part of this investigation.The translator strut was found to be broken where the 3mm diameter pin passes through.The weld at this pin was found to have broken and the pin is no longer static to the joint component.There is rust on the device surface where the components mate, mainly focused around the connections with the pins.This complaint is confirmed.Replication of the complaint condition is not applicable.Relevant drawings were reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for the intended use when employed.The broken strut is likely due to excessive force during use.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-LEFT
• Common Device Name: MISC ORTHO SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• MDR Report Key: 6449760
• Report Number: 9680938-2017-10061
• Device Sequence Number: 16258860
• Product Code: LXH
• UDI-Device Identifier: 10705034777511
• UDI-Public: (01)10705034777511(10)T939595
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 03/10/2017

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: 396.395
• Device Lot Number: T939595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2017
• Supplement Report FDA Received Date: 05/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1