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

Model Number	03.010.112
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Device received 10/7/2019.A review of the device history record.Device history lot: part # 03.010.112, synthes lot number: 5220718, manufacturing site: synthes brandywine, release to warehouse date: 26-june- 2006.Device history batch null, device history 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.Investigation summary background: libertas: it was reported that on (b)(6) 2019, a holding sleeve with locking device did not function during reverse logistics audit of the returned devices at millstone.There was no patient involvement and no additional information is available.This complaint involves one (1) device.Investigation flow: visual.Visual inspection: the holding sleeve with locking device (p/n: 03.010.112, lot # 5220718) was returned and received at us cq.Upon visual inspection, it was observed that the device was missing a coupling sleeve and captivation nut.No other signs of damage was observed with the returned components of the device.Document/specification review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed.Holding sleeve: 03_010_112, rev.E/c.The device received is missing components.Hence, conforming the allegation.Conclusion: the complaint condition is confirmed for the holding sleeve with locking device (p/n: 03.010.112, lot # 5220718) due to missing components.There is no indication that a design or manufacturing issue has caused it and hence the root cause cannot be determined.Potential cause could be due to sterilization and device use.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
Libertas: it was reported that on (b)(6) 2019, a holding sleeve with locking device did not function during reverse logistics audit of the returned devices at millstone.There was no patient involvement and no additional information is available.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: HOLDING SLEEVE WITH LOCKING DEVICE
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9252728
• Report Number: 2939274-2019-61817
• Device Sequence Number: 2363299
• Product Code: HXX
• UDI-Device Identifier: 10886982067845
• UDI-Public: (01)10886982067845
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2019

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: 5220718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 10/29/2019
• Patient Sequence Number: 1