MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE INSERTER; MISC ORTHO SURGICAL INSTR

Model Number	357.372
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product investigation was conducted.Visual inspection: the helical blade inserter (part # 357.372/ lot # 6575600) was received at us cq.The alignment indicator component was broken as the dowel pin that slots into the guide shaft was broken.The locking shaft of the alignment indicator was missing.Due to the noted damage, the device is not able to function appropriately.The alignment tab is not able to properly secure onto the assembly thus the entire assembly does not function.Dimensional inspection: dimensional inspection was not performed due to post-manufacturing damage document/specification review: drawing(s) reviewed: (current & manufactured revisions) conclusion: the overall complaint was confirmed for the received helical blade inserter as the alignment indicator was broken thus the assembly does not function.Although no definitive root-cause can be determined its possible the device experienced unintended forces.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.A device history record (dhr) review was conducted: part # 357.372, synthes lot # 6575600, supplier lot # na, release to warehouse date: 26 jan 2011, manufactured by (b)(4).No ncr's were generated during production.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 on (b)(6) 2020, one (1) helical blade inserter, six (6) locking bolt measuring device and two (2) depth gauge for locking screw were broken and one (1) helical blade inserter does not function during reverse logistics audit of the returned device at millstone.There was no patient involvement and no additional information is available.During manufacturer's preliminary evaluation of the received device it was identified that a helical blade inserter is missing components.This report is for one (1) helical blade inserter.This is report 10 of 10 (b)(4).

• Brand Name: HELICAL BLADE INSERTER
• 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: 9735106
• Report Number: 2939274-2020-00952
• Device Sequence Number: 329726
• Product Code: LXH
• UDI-Device Identifier: 10886982196064
• UDI-Public: (01)10886982196064
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2020

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: 357.372
• Device Catalogue Number: 357.372
• Device Lot Number: 6575600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1