MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	357.372
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is an unknown date in 2021.Reporter is a synthes employee.Part: 357.372, synthes lot: 7874232, supplier lot: n/a, release to warehouse date: december 18, 2014, manufacturer: (b)(4).No nonconformance reports (ncrs) 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.Service and repair evaluation: the customer reported that the device was defective.The repair technician reported that the centering pin on the alignment cap was broken.Damaged component is the reason for repair.The cause of the issue is unknown.The following parts were replaced: replacement alignment.The item was repaired per the inspection sheet, passed synthes final inspection and will be returned to the customer upon completion of the service and repair process.Finalized service record will be archived.The evaluation was confirmed.The device was deemed serviceable and will be returned to the customer; no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.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.Date of event is an unknown date in 2021.Reporter is a synthes employee.Part: 357.372, synthes lot: 7874232, supplier lot: n/a, release to warehouse date: december 18, 2014, manufacturer: (b)(4).No nonconformance reports (ncrs) 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.Service and repair evaluation: the customer reported that the device was defective.The repair technician reported that the centering pin on the alignment cap was broken.Damaged component is the reason for repair.The cause of the issue is unknown.The following parts were replaced: replacement alignment.The item was repaired per the inspection sheet, passed synthes final inspection and will be returned to the customer upon completion of the service and repair process.Finalized service record will be archived.The evaluation was confirmed.The device was deemed serviceable and will be returned to the customer; no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.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
Device report from (b)(6) reports an event as follows: it was reported that during a procedure on an unknown date, the helical blade inserter was defective; still operational but defective.Procedure outcome is unknown.There was no patient consequence.Upon manufacturer investigation, it was determined that the device was broken.This report is for a helical blade inserter.This is report 1 of 1 for (b)(4).

• Brand Name: HELICAL BLADE INSERTER
• 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: 12188681
• Report Number: 2939274-2021-04149
• Device Sequence Number: 2795996
• Product Code: LXH
• UDI-Device Identifier: 10886982196064
• UDI-Public: (01)10886982196064
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/31/2021

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: 7874232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 07/19/2021
• 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: HELICAL BLADE COUPLING SCREW