MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TENSION GAUGE; GAUGE, DEPTH

Catalog Number 00578907100

Device Problems Break (1069); Entrapment of Device (1212); Fracture (1260)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 04/26/2017

Event Type  Injury  

Event Description

Upon unicompartmental implantation the device was inserted to provide compression as the cement hardened.The device broke in two.Upon breaking the smaller piece became entrapped in the posterior capsule.The piece could not be retrieved so the unicompartmental knee was explanted, the broken piece was extracted and the unicompartmental knee was converted to a legion tka.Surgery was extended due to this.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Please review attached for investigation results.(b)(4).

• Brand Name: TENSION GAUGE
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau 05001 ; SZ 05001
• MDR Report Key: 6584047
• MDR Text Key: 75733238
• Report Number: 1020279-2017-00364
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/02/2017

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00578907100
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/05/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2017
• Initial Date FDA Received: 05/23/2017
• Supplement Dates Manufacturer Received: 04/26/2017; 10/05/2017; 10/05/2017
• Supplement Dates FDA Received: 09/21/2017; 10/18/2017; 11/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention