MAUDE Adverse Event Report: KARL STORZ SE & CO. KG METAL MALLET, LIGHT MODEL, 18 CM; SURGICAL MALLET

Model Number 174700

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that there was event with a "metal mallet".According to the information received, the mallet head became loos from the handle - glue is in place.No patient injury, but consultant received light injury.Further information is not available.

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 22-0074 corrective action 6.The event is filed under internal karl storz complaint id ((b)(4)).The hammer shows heavy signs of use on the head and should not have been used as it is - presumed cause of damage is overloading.The glue between the style and the head is present, but broken.The instrument was in use for three years.

• Brand Name: METAL MALLET, LIGHT MODEL, 18 CM
• Type of Device: SURGICAL MALLET
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 17258609
• MDR Text Key: 318483392
• Report Number: 9610617-2023-00892
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT-D0601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 174700
• Device Catalogue Number: 174700
• Device Lot Number: TS01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other