MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT T8; GUIDE

Model Number	314.468
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is jnj representative.Investigation summary: investigation flow: visual.Visual inspection: the holding sleeve for stardrive screwdriver shaft t8 (p/n: 314.468, lot #: 5245529) was returned and received at us cq.Upon visual inspection, it was observed that the device was missing a spring.No other issues were identified with the returned device.Service and repair evaluation: the customer reported that the holding sleeve was missing a piece.The repair technician reported the device spring is missing, there is no component to repair the item.Missing parts is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Complaint confirmed? yes, the device received was missing a component.Hence confirming the allegation.Investigation conclusion the complaint condition was confirmed for the holding sleeve for stardrive screwdriver shaft t8 (p/n: 314.468, lot #: 5245529).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to device maintenance or incorrectly assembled during sterilization process.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 # 314.468, synthes lot # 5245529, supplier lot # na, release to warehouse date 06/06/2006, manufactured by synthes (b)(4).Mrr # (b)(4) was generated for a missing etch.This non-conformance is not relevant to the complaint condition since etch was found at final inspection.Device history review: review of the device history record(s) showed that there were no issues during the manufacture of the product that 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 at a loaner set, it was observed that the holding sleeve was missing a piece.There was no known patient or hospital involvement.This complaint involves one (1) device.This report is for (1) holding sleeve for stardrive screwdriver shaft t8.This report is 1 of 1 for (b)(4).

• Brand Name: HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT T8
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11089559
• Report Number: 2939274-2020-05755
• Device Sequence Number: 14135979
• Product Code: FZX
• UDI-Device Identifier: 10886982188939
• UDI-Public: (01)10886982188939
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/01/2020

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: 314.468
• Device Catalogue Number: 314.468
• Device Lot Number: 5245529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 12/29/2020
• Patient Sequence Number: 1