MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOLDING SLEEVE 45 FOR MEDIUM DISTRACTOR; APPARATUS, TRACTION, NON-POWERED

Model Number	395.45
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, the following devices were received as blind unit.This report is for one (1) holding sleeve 45 for medium distractor.This is report 1 of 4 for complaint (b)(4).
Additional Manufacturer Narrative
Additional narrative: reporter is a j&j employee.A device history record (dhr) review was conducted: visual inspection: the holding sleeve 45 for medium distractor was returned and received at us cq.Upon visual inspection, it was observed that the wing screw is broken.No other issues were identified with the returned device.Dimensional inspection: the dimensional inspection is not performed due to the post manufacturing damage.Document/specification review due to unknown manufacturing date, all the available drawings in the system were reviewed.Investigation conclusion the complaint condition was confirmed for the holding sleeve 45 for medium distractor.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot - the following part/lot combination is unknown.If more information become available, the record will be re-assessed.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: HOLDING SLEEVE 45 FOR MEDIUM DISTRACTOR
• Common Device Name: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13266405
• Report Number: 2939274-2022-00188
• Device Sequence Number: 20023743
• Product Code: HST
• UDI-Device Identifier: 10886982200327
• UDI-Public: (01)10886982200327
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 395.45
• Device Catalogue Number: 395.45
• Device Lot Number: 29P4843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 01/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.0 SELF-DRILLING SCHANZ SCR 60 THRD/175; 5MM HEX FLEXIBLE SCREWDRIVER; 5MM HEX SCREWDRIVER SHAFT; DEPTH GAUGE F/LOCK-SCR MEAS-RANGE-110 F/; DOUBLEJOINT CPL F/MED-DISTRACT; DRIVING CAP F/INSERTION HANDLE; NUT-KNURLED F/MED-DISTRACT; RADIOLUCENT INSERTION HANDLE FRN; SLID-CARRIAGE W/ADJUST-NUT F/MED-DISTRAC
• Patient Sex: Unknown