MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CURVED DISTRACTOR-SMALL; MISC ORTHO SURGICAL INSTR

Model Number	389.026
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
Investigation summary: investigation flow: damage.Visual inspection: the curved distractor-small (p/n: 389.026, lot #: a7 ja 50) was returned and received at us cq.Upon visual inspection, it was observed that the distal tip of the upper jaw was broken and the broken fragment was not returned.Rust was observed at the broken portion of the device.There were scratches on the device but have no impact on the device functionality.No other issues were identified with the returned device.The device failure/defect is identified.Dimensional inspection: a dimensional inspection was performed on the returned device.Document/specification review: due to the age of the device and source controlled drawings, manufactured revision drawing is no longer available.The device received was broken.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed for the curved distractor-small (p/n: 389.026, lot #: a7 ja 50).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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 history lot: part number: 389.026.Lot number: a7ja50.Manufacturing site: (b)(4).Release to warehouse date: week 50, 2000.A review of the device history records is not possible, the dhr is no longer available due to the age of the instrument (over 19 years old).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, during an inspection of set at loaners department, the curved distractor-small tip broken.There was no patient involvement.This complaint involves (1) device.This report is for (1) curved distractor-small.This is report 1 of 1 for (b)(4).

• Brand Name: CURVED DISTRACTOR-SMALL
• 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: 10773230
• Report Number: 2939274-2020-04937
• Device Sequence Number: 17165549
• Product Code: LXH
• UDI-Device Identifier: 10705034774015
• UDI-Public: (01)10705034774015
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 10/06/2020

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: 389.026
• Device Catalogue Number: 389.026
• Device Lot Number: A7 JA 50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1