MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HAT-TRICK PIP FUS 2.7MMPROX 4MM10DEG+MID; SCREW, FIXATION, BONE

Model Number	72204370
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the implant broke upon insertion into the proximal phalanx.Site was tapped before insertion into very hard bone.The broken implant was drilled out & retapped with 2.7 tap.A new implant was opened & completed the case without further issue and there was no patient injuries reported.
Additional Manufacturer Narrative
One (b)(4) implant kit was returned for evaluation.Visual assessment confirmed the reported breakage.The proximal phalanx has broken transversely at its threaded distal end.The broken portion was not returned for examination.Dimensional assessment of the proximal phalanx portion that was returned confirmed it met print specification.This investigation could not identify any evidence of product contribution to the reported problem.

• Brand Name: HAT-TRICK PIP FUS 2.7MMPROX 4MM10DEG+MID
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 6984025
• Report Number: 1219602-2017-01341
• Device Sequence Number: 1677132
• Product Code: HWC
• UDI-Device Identifier: 00885554034943
• UDI-Public: (01)00885554034943(17)200302(10)50650596
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K133515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2017

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 Expiration Date: 03/01/2020
• Device Model Number: 72204370
• Device Catalogue Number: 72204370
• Device Lot Number: 50650596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Initial Date Received by Manufacturer: 10/25/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 10/27/2017
• Supplement Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR