MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ELITE COMPRESSION IMPLANT DRILLING TEMPLATES; STAPLE,FIXATION,BONE

Model Number	EL-DTS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Bme part number not in jde.Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Patient code used for: the complaint indicated that the device broke intra-op requiring additional surgical intervention/change in surgical plan.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.Investigation summary: dhr review could not be conducted due the insufficient information¿s.Product was not returned and no lot number was provided.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.
Event or Problem Description
It was reported that the 20mm drill guide for the 2-leg elite staple sizing guides broke when the doctor put the drill bit into it during a procedure on (b)(6) 2018.This was the 4th use of the guide during the surgery.The doctor did not drill through the 20mm guide after it broke.He switched to an 18mm guide and used and 18x18 elite staple.There was no delay in surgery time and no patient issues.There is no additional information.Concomitant device(s): drill bit (part #: unknown, lot #: unknown, qty: 1).This report is 1 of 1 for (b)(4).

• Brand Name: ELITE COMPRESSION IMPLANT DRILLING TEMPLATES
• Common Device Name: STAPLE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7397109
• Report Number: 2939274-2018-51437
• Device Sequence Number: 723146
• Product Code: JDR
• UDI-Device Identifier: 00810633021965
• UDI-Public: (01)00810633021965(10)LOTUNK
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K150125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EL-DTS
• Device Catalogue Number: EL-DTS
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2018
• Initial Report FDA Received Date: 04/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention