MAUDE Adverse Event Report: RAYNHAM RANEYSCLP CLP DSPOSE -200; SCALP CLIPS

Catalog Number 201037

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported a broken scalp clip after surgery.It is unknown if any part fell into the surgical site as they were not able to find a broken piece.When device broke, they searched for the fragment, however, not all broken parts were recovered.

Manufacturer Narrative

Unique device identification (udi): (b)(4) or (b)(4).The raneyscalp clip was not returned for evaluation and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.A photo was provided which showed a broken scalp clip.Therefore the report of a broken scalp clip is confirmed.However, it is noted that the photo and description does not provide much description of how the device was used, therefore the risk documentation will be used to assess the potential causes of this broken scalp clip.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.Product was not received for analysis, however a photo was provided which showed the broken scalp clip.Therefore, the report of a broken scalp clip was confirmed.Due to not having the product for testing, the risk documentation was used to determine the potential root causes of this failure.Potential root causes include clinician opens scalp clip too far, or improper material selection/dimension attributes/tolerances.

Event Description

N/a.

• Brand Name: RANEYSCLP CLP DSPOSE -200
• Type of Device: SCALP CLIPS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• MDR Report Key: 12304371
• MDR Text Key: 266020759
• Report Number: 3014334038-2021-00160
• Device Sequence Number: 1
• Product Code: HBO
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 201037
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/22/2021
• Initial Date FDA Received: 08/10/2021
• Supplement Dates Manufacturer Received: 09/03/2021
• Supplement Dates FDA Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1