MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ADJUSTABLE CERVICAL DISTRACTOR-RIGHT; MISC ORTHO SURGICAL INSTR

Model Number	396.396
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Service and repair evaluation: the customer reported the adjustable cervical distractor arm was broke off at its weld point during the removal of the instrument from the distraction pins.The repair technician reported the fix guide is broken.Supplier is unable to repair 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.The investigation is done based on the supplied image(s).The image(s) was reviewed and the complaint condition could be confirmed as the image shows the distractor broken.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.A device history record (dhr) review was conducted: part number: 396.396, lot number: a7ka51, manufacturing site: (b)(4), release to warehouse date: (b)(4) 2001.A review of the device history records is not possible, the dhr is no longer available due to the age of the instrument (over 18 years old).Device was used for treatment, not diagnosis.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 on (b)(6) 2020, patient underwent anterior cervical fusion procedure.During the procedure the adjustable cervical distractor arm broke off at its weld point while removing the instrument from the distraction pins and while preparing to move it to the next operative level to be worked on.There is no surgical delay reported.Procedure was successfully completed.There is no patient consequence reported.Concomitant device reported: unknown distraction pins (part#: unknown, lot#: unknown, quantity 1).This report is for one (1) adjustable cervical distractor-right.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h4, h6 investigation summary: visual inspection: (updated based on device receipt): the adjustable cervical distractor-right (p/n: 396.396, lot #: a7ka51) was returned and received at us cq.Upon visual inspection, the device was observed to be broken.No other issues were identified with the returned device.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Service and repair evaluation: the customer reported the adjustable cervical distractor arm was broke off at its weld point during the removal of the instrument from the distraction pins.The repair technician reported the fix guide is broken.Supplier is unable to repair 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.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Adjustable cervical distractor.Complaint confirmed? yes, the device received was broken.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed for the adjustable cervical distractor-right (p/n: 396.396, lot #: a7ka51).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10593937
• Report Number: 2939274-2020-04345
• Device Sequence Number: 10855829
• Product Code: LXH
• UDI-Device Identifier: 10705034777528
• UDI-Public: (01)10705034777528
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/02/2020

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 Model Number: 396.396
• Device Catalogue Number: 396.396
• Device Lot Number: A7KA51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 10/16/2020; 10/16/2020
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 10/16/2020; 10/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN DISTRACTION PINS.; UNKNOWN DISTRACTION PINS
• Patient Age: 81 YR
• Patient Weight: 87