MAUDE Adverse Event Report: MERETE GMBH PEDIATROS RIGIDTACK; BONE STAPLE

Model Number	CP20120
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Merete was informed by a distributor in (b)(6) that discrepancies between product labeling and a marketing label occurred.The discrepancy is evident as the product label, clearly indicating a cp20120/ lot: ms2117816, which is a size 20 mm staple, but the marketing label indicating the device as a size 25 mm staple.The mislabeled marketing label is affixed on the complete lot.Therefore a recall of this lot was initiated.Other lots and products can be excluded since the failure is not transferable.Please note: this report is filed with the fda due to a malfunction which could lead to serious injury with a device that is also placed on the market in the usa, however, this event occurred outside of the usa.
Event or Problem Description
Merete was informed by a distributor in (b)(6) that discrepancies between product labeling and a marketing label occurred.The discrepancy is evident as the product label, clearly indicating a cp20120/ lot: ms2117816, which is a size 20 mm staple, but the marketing label indicating the device as a size 25 mm staple.

• Brand Name: PEDIATROS RIGIDTACK
• Common Device Name: BONE STAPLE
• Manufacturer (Section D): MERETE GMBH; alt-lankwitz 102; berlin, berlin 12247 ; GM 12247
• Manufacturer (Section G): MERETE GMBH; alt-lankwitz 102; berlin, berlin 12247 ; GM 12247
• Manufacturer Contact: paul münch ; alt-lankwitz 102; berlin, berlin 12247 ; GM 12247
• MDR Report Key: 13384431
• Report Number: 3002949614-2022-00001
• Device Sequence Number: 4494512
• Product Code: JDR
• UDI-Device Identifier: 04048266150394
• UDI-Public: (01)04048266150394(17)260706(10)MS2117816
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 01/18/2022

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 Expiration Date: 07/21/2021
• Device Model Number: CP20120
• Device Catalogue Number: CP20120
• Device Lot Number: MS2117816
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown