MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SMALL UNIVERSAL CHUCK WITH T-HANDLE; MISC ORTHO SURGICAL INSTR

Model Number	393.105
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
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.Reporter is synthes sales consultant.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, one of the tips of the small universal chuck with t-handle broke and the tip was thrown away during cleaning in the sterile processing department (spd).There was no patient involvement.  this report is for one (1) small universal chuck with t-handle.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.The small universal chuck with t-handle (p/n 393.105 lot l038140) was returned and received.A visual inspection was performed.One of the three clamping jaws were observed to have fallen apart from the instrument and was missing.There was no indication of breakage on the instrument.The tips of the remaining two jaws and distal end of the chuck cone were observed to be worn and damaged from impaction.No other issues were identified with the returned components of the device.Dimensional inspection was not performed due to post manufacturing damage.The complaint was confirmed for the small universal chuck with t-handle (p/n 393.105 lot l038140) as one of the three clamping jaws were observed to have fallen apart from the instrument and was missing.There was no indication of breakage on the instrument.The tips of the remaining two jaws and distal end of the chuck cone were observed to be worn and damaged from impaction.There was no indication that a design or manufacturing issue contributed to the complaint.Although a definitive root cause could not be determined, it is possible that the conditions are due to unintended forces, rough handling, and/or consistent use and reprocessing over the part¿s lifetime (2+ years).Based on the investigation findings, it was 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: 393.105, lot: l038140, manufacturing site: hägendorf, release to warehouse date: 04 nov 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.
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.Device history lot: part: 393.105.Lot: l038140.Manufacturing site: hägendorf.Release to warehouse date: 04 nov 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The small universal chuck with t-handle (p/n 393.105 lot l038140) was returned and received.A visual inspection was performed.One of the three clamping jaws were observed to have fallen apart from the instrument and was missing.There was no indication of breakage on the instrument.The tips of the remaining two jaws and distal end of the chuck cone were observed to be worn and damaged from impaction.No other issues were identified with the returned components of the device.The complaint was confirmed for the small universal chuck with t-handle (p/n 393.105 lot l038140) as one of the three clamping jaws were observed to have fallen apart from the instrument and was missing.There was no indication of breakage on the instrument.The tips of the remaining two jaws and distal end of the chuck cone were observed to be worn and damaged from impaction.There was no indication that a design or manufacturing issue contributed to the complaint.Although a definitive root cause could not be determined, it is possible that the conditions are due to unintended forces, rough handling, and/or consistent use and reprocessing over the part¿s lifetime (2+ years).Based on the investigation findings, it was 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: SMALL UNIVERSAL CHUCK WITH T-HANDLE
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8684713
• Report Number: 2939274-2019-58579
• Device Sequence Number: 2292785
• Product Code: LXH
• UDI-Device Identifier: 10886982199034
• UDI-Public: (01)10886982199034
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2019

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: 393.105
• Device Catalogue Number: 393.105
• Device Lot Number: L038140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 06/20/2019; 06/21/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 06/21/2019; 06/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1