MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPINDLE FOR EVOLUTION; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	03.825.002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The spindle for evolution (part #:03.825.002, lot #: h143328) was returned and received at us cq.Upon visual inspection, it was observed that the weld connecting the knob with the spindle was broken allowing the knob to rotate and disassemble from the spindle.No other issues were identified with the returned device.The complaint condition is confirmed for the spindle for evolution (part #: 03.825.002, lot #: h143328).No definitive root-cause can 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 history lot: part #: 03.825.002, synthes lot #: h143328, supplier lot #: h143328, release to warehouse date: (b)(4) 2016, supplier: (b)(4).The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which 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.
Event or Problem Description
It was reported that on an unknown date, during a routine incoming inspection of a loaner set at fsl ups malden, ma site, it was observed that a spindle for evolution was broken.There was no known patient or hospital involvement.This report is for one (1) spindle for evolution.This is report 1 of 1 for (b)(4).

• Brand Name: SPINDLE FOR EVOLUTION
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10741177
• Report Number: 2939274-2020-04832
• Device Sequence Number: 19618305
• Product Code: LXH
• UDI-Device Identifier: 10705034732022
• UDI-Public: (01)10705034732022
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 09/29/2020

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: 03.825.002
• Device Catalogue Number: 03.825.002
• Device Lot Number: H143328
• 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: 09/29/2020
• Initial Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1