MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM UNIVERSAL DRILL GUIDE; GUIDE, SURGICAL, INSTRUMENT

Model Number	323.46
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a j&j employee.The investigation could not be completed.No conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.Part: 323.46.Lot: 5417136.Supplier lot number: n/a.Manufacture date or release to warehouse date: january 17, 2007.Expiration date: n/a.Supplier/manufacture site: (b)(4).No nonconformance reports (ncrs) were generated during assemble production of lot 5417136.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Service and repair evaluation: during routine incoming inspection of a loaner set, it was observed that the drill guide was broken.The repair technician reported the device is missing the spring, threaded nipple, and drill sleeve.Missing parts is the reason for repair.The cause of the issue is unknown.The following parts were replaced: spring, threaded nipple, drill sleeve.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.
Event or Problem Description
It was reported that during a routine inspection of a loaner set it was observed that the universal drill guide was broken at fsl ups lyndhurst, nj site.No patient involvement.This report is for one (1) 4.5mm universal drill guide.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 4.5MM UNIVERSAL DRILL GUIDE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11613511
• Report Number: 2939274-2021-01672
• Device Sequence Number: 14252160
• Product Code: FZX
• UDI-Device Identifier: 10886982190857
• UDI-Public: (01)10886982190857
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Type of Report: Initial
• Report Date (Section B): 03/08/2021

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: 323.46
• Device Catalogue Number: 323.46
• Device Lot Number: 5417136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1