MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC RAPID RESORBABLE CRANIAL CLAMP 18MM; COVER, BURR HOLE

Model Number	851.801.01S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is for an unknown number of unknown clamps - unknown lot.Additional procode hbw.Complainant part has not been returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 there were reports of breakage of the implant during implantation from a survey by the clinical team filled out by one surgeon who had used the rapidsorb cranial clamp.The actual number of cases that these malfunctions have occurred in is unknown.This is because based on the survey design, the percentages of malfunctions and adverse events are as per the surgeon's perception and may not be an actual calculated number.The surgeon has been involved in at least twenty-one (21) surgeries of children with the rapidsorb cranial clamp.This complaint involves one (1) device.This report is for an unknown number of clamps.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Reporter information.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.
Additional Manufacturer Narrative
Additional narrative: received date was left blank in (b)(4) in error.The date should have been feb 09, 2018.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: RAPID RESORBABLE CRANIAL CLAMP 18MM
• Common Device Name: COVER, BURR HOLE
• Manufacturer (Section D): WRIGHTS LANE: SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7205459
• Report Number: 2939274-2018-50305
• Device Sequence Number: 10793729
• Product Code: HBW
• UDI-Device Identifier: 10887587064239
• UDI-Public: (01)10887587064239(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K041611
• 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,Followup,Followup
• Report Date (Section B): 12/21/2017

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 Model Number: 851.801.01S
• Device Catalogue Number: 851.801.01S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/21/2017
• Supplement Date Received by Manufacturer: 02/09/2018; 02/09/2018; 02/14/2018
• Initial Report FDA Received Date: 01/19/2018
• Supplement Report FDA Received Date: 02/09/2018; 02/09/2018; 02/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1