MAUDE Adverse Event Report: SMITH & NEPHEW, INC. G2 INS SPAC TR SZ7-8 13MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	71430230
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the spacer broke during surgery.Used an identical backup device to complete surgery.Surgery time was not extended more than 30 min.The surgeon does not fault the device.The patient or surgical procedure was not affected in any way due to the problem.Absolutely no broken pieces fell into the patient¿s wound at all.Tracking number is not available at this time, but, item will be returned to the appropriate address.
Additional Manufacturer Narrative
The associated complaint device was not returned.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: G2 INS SPAC TR SZ7-8 13MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8624131
• Report Number: 1020279-2019-01958
• Device Sequence Number: 13945108
• Product Code: LXH
• UDI-Device Identifier: 03596010211880
• UDI-Public: 03596010211880
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2019

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: 71430230
• Device Lot Number: 05DM07508
• Initial Date Received by Manufacturer: 04/22/2019
• Supplement Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 11/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1