MAUDE Adverse Event Report: PRO MED INSTRUMENTS GMBH DORO DISPOSABLE SKULL PINS; DISPOSABLE SKULL PINS,ADULT (36PCS)

Model Number 3006-00

Device Problems Device Slipped (1584); Device Operates Differently Than Expected (2913)

Patient Problem Not Applicable (3189)

Event Type  malfunction  

Manufacturer Narrative

The information received by the customer indicate, that there might have been an incident due to a possible breakage of the pin.As we did not receive the product for inspection we could not confirm or exclude any breakage.However considering the details of the customer report and considering the typical use of the product during pinning and especially during re-pinning it is very unlikely that a breakage would not have been detected by the user.We suspect other root causes for the reported incident.

Event Description

Customer mentioned on their reply form of our field safety notice 3006-00, lot 17072 and 17041 the following: since recall was reported to surgeon, he reported, his last three patients had issues with the products.This reply form was received on november 2nd 2017.Pmi contacted the customer via phone on (b)(6) without success and wrote an email on (b)(6) to request further information about the described incidents.In an e-mail reply customer stated that there were no injuries but that the surgeon has indicated that there was some initial slippage of the pins whereby the cranium did maintain position, which was never a problem before the affectt lot was in use.

• Brand Name: DORO DISPOSABLE SKULL PINS
• Type of Device: DISPOSABLE SKULL PINS,ADULT (36PCS)
• Manufacturer (Section D): PRO MED INSTRUMENTS GMBH; boetzinger str. 38; freiburg, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer (Section G): PRO MED INSTRUMENTS GMBH; boetzinger str. 38; freiburg, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer Contact: sandra untenberger ; boetzinger str. 38; freiburg, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 7057627
• MDR Text Key: 93694834
• Report Number: 3003923584-2017-00050
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 3006-00
• Device Catalogue Number: 3006-00
• Device Lot Number: 17041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/26/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention