MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DHS/DCS CENTERING SLEEVE LONG; GUIDE, SURGICAL, INSTRUMENT

Model Number	338.19
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 an equipment assembly in sterile processing, it was discovered that the dhs/dcs wrench was sticking with interface of dhs/dcs centering sleeve.There was no patient involvement.This report is for one (1) dhs®/dcs® centering sleeve long.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6: part 338.190, lot 8805183: manufacturing site: hägendorf.Release to warehouse date: march 04, 2014.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: a product investigation was completed: upon visual inspection, it was observed that the internal sleeve portion was slightly deformed.There are scratches on the device but have no impact on the device functionality.No other issues were observed with the returned device.A functional test was performed on the returned devices.When the wrench was inserted into the centering sleeve, slight resistance was observed but was able to insert fully with some force applied.The sleeve was observed to be deformed internally which could have caused the complaint condition.No dimensional inspection can be performed due to post-manufacturing damage.Based on the date of manufacture, the current and manufactured revision of drawings were reviewed.The complaint condition was confirmed.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 unintended forces applied to the device.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.

• Brand Name: DHS/DCS CENTERING SLEEVE LONG
• 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: 11078142
• Report Number: 2939274-2020-05720
• Device Sequence Number: 16887773
• Product Code: FZX
• UDI-Device Identifier: 10886982193216
• UDI-Public: (01)10886982193216
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 11/30/2020

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: 338.19
• Device Catalogue Number: 338.190
• Device Lot Number: 8805183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DHS®/DCS® WRENCH; DHS®/DCS® WRENCH