MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC NORIAN DRILLABLE FAST SET PUTTY 10CC-STERILE; FILLER, CALCIUM SULFATE PREFORMED PELLETS

Model Number	07.704.110S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Incident occured intra-operative.Device was not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.((b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review is pending completion.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2018, patient underwent initial surgery for open reduction internal fixation of proximal humerus fracture.During the surgery, norian drillable fast set putty 10cc-sterile was pulled out from pyxis system and temperature indicator turned black.There was five minutes delay in procedure as surgeon has to use norian drillable fast set putty 3 cc sterile and norian drillable fast set putty 5 cc sterile to complete the procedure successfully.Surgeon mentioned that he needed more norian but completed surgery with 3cc and 5cc norian putty.Patient was reported as stable post operatively.Additionally, it was noted that 3 cc, 5 cc, and 10 cc norian were all stored in same pyxis system at same temperature.This report is for one (1) norian drillable fast set putty 10cc sterile.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device history record (dhr) review: manufacturing location: (b)(4).Packaged by: (b)(4), manufacturing date: 14-sep-2017, expiration date: 28-aug-2018: part #: 07.704.110s, lot#: dse2628 (sterile) - norian drillable fast set 10cc - sterile.Quantity 109: inspection sheet for incoming final inspection met inspection acceptance criteria.Certificate of conformance received from dsm meet specification.No non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Sterility documentation was reviewed and determined to be conforming.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: NORIAN DRILLABLE FAST SET PUTTY 10CC-STERILE
• Common Device Name: FILLER, CALCIUM SULFATE PREFORMED PELLETS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7266631
• Report Number: 2939274-2018-50604
• Device Sequence Number: 1455285
• Product Code: MQV
• UDI-Device Identifier: 10886982131652
• UDI-Public: (01)10886982131652(17)180828(10)DSE2628
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K102722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2018

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 Expiration Date: 08/28/2018
• Device Model Number: 07.704.110S
• Device Catalogue Number: 07.704.110S
• Device Lot Number: DSE2628
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 03/23/2018
• 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: Required Intervention
• Patient Age: 53 YR
• Patient Weight: 94