MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GRFTMSTR E'BTN HLDR; TEMPLATE

Model Number	014415
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/26/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the measuring scale is not accurate, +3 to 4mm.Therefore the graft (btb) was to long and has to be shortened intraoperatively.No patient injuries were reported.
Additional Manufacturer Narrative
One 014415 graftmaster endobutton holder returned.The product is 1 year old.The complaint says: ¿it was reported that the measuring scale is not accurate, +3 to 4mm.Therefore the graft (btb) was too long and has been to be shortened intraoperatively¿.Dimensional evaluation confirmed that the 10 to 20 mm distance is 10mm and the 60 to 70 distance is 10mm.The actual distances between the rest of the 10mm increments measure under spec; less than 10mm for each 10mm incremental distance between the 20mm to 60mm positions.0 to 10 is unknown as the drawing does not call out the zero starting position.This complaint was tasked to engineering for deeper evaluation.Engineering response: failure mode was confirmed by quality engineering.

• Brand Name: GRFTMSTR E'BTN HLDR
• Common Device Name: TEMPLATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7087595
• Report Number: 1219602-2017-01524
• Device Sequence Number: 1182936
• Product Code: HWT
• UDI-Device Identifier: 03596010397362
• UDI-Public: (01)03596010397362(10)50638040
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2018

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 Model Number: 014415
• Device Catalogue Number: 014415
• Device Lot Number: 50638040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Initial Date Received by Manufacturer: 11/27/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 02/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1