MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOLDING SLEEVE WITH LOCKING DEVICE; SCREWDRIVER

Model Number	03.010.112
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 a synthes employee.Part: 03.010.112.Synthes lot: 5381283.Supplier lot: na.Release to warehouse date: march 06, 2007.Manufactured by synthes (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.Visual inspection: the holding sleeve with locking device was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the device was missing the coupling sleeve component.No other issues were observed with the returned device.Dimensional inspection: there was conclusive evidence that the returned device was missing components, so the dimensional inspection was not performed.Based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Holding sleeve.The complaint condition was confirmed for the holding sleeve with locking device.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 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 during a routine incoming inspection of a loaner set on an unknown date, it was observed that the holding sleeve with locking device was missing a piece.There was no known patient or hospital involvement.This report is for a holding sleeve with locking device.This is report 1 of 1 for (b)(4).

• Brand Name: HOLDING SLEEVE WITH LOCKING DEVICE
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11960693
• Report Number: 2939274-2021-02840
• Device Sequence Number: 14343961
• Product Code: HXX
• UDI-Device Identifier: 10886982067845
• UDI-Public: (01)10886982067845
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 04/12/2021

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: 03.010.112
• Device Catalogue Number: 03.010.112
• Device Lot Number: 5381283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1