MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ADJUSTABLE PARALLEL WIRE GUIDE

Model Number	312.73
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that on (b)(6) 2020, the adjustable parallel wire guide was found to be broken in sterile processing department (spd).There was no patient involvement.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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.H3, h4, h6: a review of the device history record.Device history lot: part number: 312.73.Synthes lot number: a4bd408.Supplier lot number: n/a.Release to warehouse date: 28sep1992.Expiration date: n/a.Manufactured by synthes brandywine.No ncrs were generated during production.Device history batch null, device history review review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.H3, h6: investigation summary background: it was reported that on march, 25, 2020, the adjustable parallel wire guide was found to be broken in sterile processing department (spd).There was no patient involvement.This complaint involves one (1) device.Investigation flow: damage.Visual inspection: the adjustable parallel wire guide (product code: 312.73, lot number: a4bd408) was received at us cq for investigation.Visual inspection of the received device indicated that the adjustable guide body proximal tip was broken in the locking nut.The broken piece was struck in the locking nut.Thus, the complaint condition was confirmed for the received device.Service and repair evaluation: the customer reported the adjustable parallel wire guide was found to be broken in sterile processing department (spd).The repair technician reported the adjustable guide body broke in locking nut and they do not have the right tools to repair.Supplier 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.Dimensional inspection: the dimensional inspection cannot be performed due to post-manufacturing damage.Document/specification review: the device was in the field and functional for approximately 28 years.The earliest manufacturing drawing available currently for this device was released on january 23, 2004.Conclusion: the overall complaint was confirmed for the received device as a component in the device was broken.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.

• Brand Name: ADJUSTABLE PARALLEL WIRE GUIDE
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9972634
• Report Number: 2939274-2020-01908
• Device Sequence Number: 2546826
• Product Code: FZX
• UDI-Device Identifier: 10886982187901
• UDI-Public: (01)10886982187901
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 312.73
• Device Catalogue Number: 312.73
• Device Lot Number: A4BD408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Initial Date Received by Manufacturer: 03/25/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 04/17/2020
• Supplement Report FDA Received Date: 05/06/2020
• Patient Sequence Number: 1