MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.7MM & SMALL SCREWS; GAUGE, DEPTH

Catalog Number	319.04
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is synthes employee.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, during an unknown procedure, the depth gauge needle broke at the base while measuring a screw hole.The surgeon used another depth gauge from another set to complete the procedure.It was unknown if there was any surgical delay.This report is for one (1) depth gauge for 2.7mm & small screws.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
The synthes monument service and repair evaluation noted a broken condition of the device at its base.The returned device was received: the measuring hook component broke at its base within the threaded region of the component.The distal end was slightly bent.A knurled cap component was not returned.No other damage was noted to the remaining components.Based on visual inspection, the received condition of the device agreed with the complaint condition.The complaint condition was confirmed.Dimensional measurements could not be taken due to the received condition of the device.During the investigation, no product design issues were observed that may have contributed to the complaint condition.The complaint condition of broken was confirmed.A missing component condition and bent condition were additionally observed.During the investigation, no product design issues or discrepancies were observed that may have contributed to the device¿s condition.There was no indication of a manufacturing issue that would have contributed to the complaint condition.While no definitive root cause could be determined it is possible that consistent usage of the device over at least 12 years with repeated use and handling during surgery and sterilization could contribute to the broken and bent condition of the device.There was no damage noted to the guide sleeve thread; it is likely the knurled cap was misplaced.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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
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: DEPTH GAUGE FOR 2.7MM & SMALL SCREWS
• Common Device Name: GAUGE, DEPTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7944957
• Report Number: 2939274-2018-54244
• Device Sequence Number: 857315
• Product Code: HTJ
• UDI-Device Identifier: 10886982189974
• UDI-Public: (01)10886982189974
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2018

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 Catalogue Number: 319.04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 11/06/2018; 12/12/2018
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 11/21/2018; 12/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1