MAUDE Adverse Event Report: STRYKER TRAUMA-MAHWAH FLEXIBLE NAIL, PRE-CURVED T2 KIDS Ø2.0X300 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	01942000S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Not available by hospital after the case.
Event or Problem Description
T2 kids flexible nail broke during insertion into redial canal.
Additional Manufacturer Narrative
The reported event that flexible nail, pre-curved t2 kids ø2.0x300 mm was alleged broken, could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
T2 kids flexible nail broke during insertion into redial canal.Update 5/31/18, rep reported that case was resolved by using a 1/3 tubular plate instead of a nail.

• Brand Name: FLEXIBLE NAIL, PRE-CURVED T2 KIDS Ø2.0X300 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7555239
• Report Number: 0009610622-2018-00229
• Device Sequence Number: 13906701
• Product Code: HSB
• UDI-Device Identifier: 07613252130611
• UDI-Public: 07613252130611
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082018
• 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,Followup
• Report Date (Section B): 08/08/2018

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 Expiration Date: 03/31/2022
• Device Catalogue Number: 01942000S
• Device Lot Number: K045785
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2018
• Supplement Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 08/08/2018
• 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: Other