MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOLDING SLEEVE FOR 3.0MM CANNULATED SCREWDRIVER; SCREWDRIVERS

Model Number	313.969
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.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Investigation summary: investigation flow: visual.Visual inspection: the holding sleeve for 3.0 mm cannulated screwdriver (p/n:313.969, lot #: 4543124) was returned and received at us cq.Upon visual inspection, it was observed that the device was missing the spring coil component.No other issues were observed with the returned components of the device.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed the complaint was confirmed.The device received was missing a component.Hence confirming the allegation.Investigation conclusion: the complaint condition is confirmed for the holding sleeve for 3.0 mm cannulated screwdriver (p/n:313.969, lot #: 4543124).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 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 number: 313.969, synthes lot number: 4543124, supplier lot number: n/a, release to warehouse date: feb 10, 2013, expiration date: n/a, manufactured by synthes (b)(4).No ncrs were generated during production.Device history review: review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, 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 that on an unknown date, during routine incoming inspection of a loaner set at dpy (b)(4) site, it was observed that the holding sleeve for 3.0mm cannulated screwdriver was found to be missing a piece.There was no known patient or hospital involvement.This complaint involves one (1) device.This report involves one (1) holding sleeve for 3.0mm cannulated screwdriver.This is report 1 of 1 for (b)(4).

• Brand Name: HOLDING SLEEVE FOR 3.0MM CANNULATED SCREWDRIVER
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11230912
• Report Number: 2939274-2021-00489
• Device Sequence Number: 3512839
• Product Code: HXX
• UDI-Device Identifier: 10886982188281
• UDI-Public: (01)10886982188281
• 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): 01/05/2021

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: 313.969
• Device Catalogue Number: 313.969
• Device Lot Number: 4543124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 01/26/2021
• Patient Sequence Number: 1