MAUDE Adverse Event Report: KLS MANUFACTURING IPS; SPLINT

Model Number	60-500-01-09
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation was performed on the basis of complaint statistics as no device was returned for evaluation.The complaint percentage was calculated, and it is determined that the complaint percentage falls within the design risk limits.During the investigation the product lot number identified was reviewed in the device history records.The dhr review showed no discrepancies or anomalies.The failure root cause cannot be determined due to no device being returned.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.
Event or Problem Description
It was reported that a splint deformed and cracked during the sterilization process.Discovered upon opening in the sterile field.A delay of 30 minutes was observed to get back-up product to complete the procedure.

• Brand Name: IPS
• Common Device Name: SPLINT
• Manufacturer (Section D): KLS MANUFACTURING; 11228 st johns industrial pkwy; jacksonville 32246
• MDR Report Key: 8176152
• Report Number: 3014483751-2018-00001
• Device Sequence Number: 19339062
• Product Code: KMY
• UDI-Device Identifier: 10888118117325
• UDI-Public: (01)10888118117325
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: CLS 1 EXEMPT
• 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
• Report Date (Section B): 11/28/2018
• Report Date (Section F): 11/28/2018

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
• Operator of Device: Health Professional
• Device Model Number: 60-500-01-09
• Device Lot Number: 8000002693
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/28/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 12/18/2018
• 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
• Patient Age: 20 YR