MAUDE Adverse Event Report: CLARIANCE SAS ERISMA-LP MIS; SCREWDRIVER SHAFT

Model Number	13911009
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	08/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the company has determined that the subject event in this mdr is likely not reportable, the company has decided to file this mdr in an abundance of caution and to ensure full compliance with 21cfr part 803.
Event or Problem Description
The tip of the erisma-lp mis screwdriver shaft was noticed to be broken after receipt from sterile processing.It is unknown if the breakage happened during surgery or elsewhere.
Event or Problem Description
The tip of the erisma-lpmis screwdriver shaft was noticed to be broken after receipt from sterile processing.It is unknown if the breakage happened during surgery or elsewhere.
Additional Manufacturer Narrative
Although the company has determined that the subject event in this mdr is likely not reportable, the company has decided to file this mdr in an abundance of caution and to ensure full compliance with 21cfr part 803.On 12/20/2019: although the company has determined that the subject event in this mdr is likely not reportable, the company has decided to file this mdr in an abundance of caution and to ensure full compliance with 21cfr part 803.The device was lost in transit to the company by the carrier.As such, no analysis was able to be performed by the manufacturer.

• Brand Name: ERISMA-LP MIS
• Common Device Name: SCREWDRIVER SHAFT
• Manufacturer (Section D): CLARIANCE SAS; 18 rue robespierre; beaurains, 62217 ; FR 62217
• MDR Report Key: 9125234
• Report Number: 3009962553-2019-00007
• Device Sequence Number: 16734440
• Product Code: HXX
• UDI-Device Identifier: 03700780627271
• UDI-Public: (01)03700780627271
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2019

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: Other
• Device Model Number: 13911009
• Device Catalogue Number: 13911009
• Device Lot Number: H632X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR