MAUDE Adverse Event Report: STRYKER GMBH SELF-DRILLING HALF PIN APEX Ø 5MM, 120 X 35MM; PIN, FIXATION, THREADED

Model Number 5018-5-120

Device Problems Break (1069); Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/16/2021

Event Type  malfunction  

Event Description

The customer reported the following issue: "when inserting in the motor a 5 mm fiche diameter of the hoffman 3 in its own guide (they verified that the guide was the correct one for the 5 mm diameter), after about 10 seconds the surgeon reported an overheating and a blockage of the fiche in the guide, as if a ¿merger¿ has happened." 1/21/2022 - additional information received from the customer: "the pin that got stuck in the guide (only one happened, then i changed the technique) obviously has the code covered, for the other pin as you can see from the other image it happened that the tip broke, which has never happened to me by heart.I confirm that i have used the drill, i know that the technique does not provide this, but i have been implanting fixators for 10 years and it had never happened to me that a pin broke, in the case of the pin that got stuck in the guide it had already happened to a colleague of mine but then we forgot to report it to you.The patient is fine, he has already been operated for the conversion to definitive synthesis with success, we only had a modest dilation of the operating times.The procedure, albeit with delay, was successfully completed.To overcome the retention of the pin fragment we had to vary the insertion technique (instead of using hole 2 and hole 4 as i usually do i used 1 and 5 leaving the "half hole" with the tip of the pin retained in position 3 obviously pin free).".

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Manufacturer Narrative

The complaint could be confirmed, since the product was returned for evaluation and matches the alleged failure.The device inspection revealed the following: visual examination of the received ¿self-drilling half pin apex ø 5mm¿ shows that the tip got plastic deformed by insertion (twisted), before it broke off, this is an indication of too much force being applied in use.Furthermore, traces of abrasion are visible on the shaft.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a use related issue, as too much force being applied.If any additional information is provided, the investigation will be reassessed.

Event Description

The customer reported the following issue: "when inserting in the motor a 5 mm fiche diameter of the hoffman 3 in its own guide (they verified that the guide was the correct one for the 5 mm diameter), after about 10 seconds the surgeon reported an overheating and a blockage of the fiche in the guide, as if a ¿merger¿ has happened." 1/21/2022 - additional information received from the cutsomer: "the pin that got stuck in the guide (only one happened, then i changed the technique) obviously has the code covered, for the other pin as you can see from the other image it happened that the tip broke, which has never happened to me by heart.I confirm that i have used the drill, i know that the technique does not provide this, but i have been implanting fixators for 10 years and it had never happened to me that a pin broke, in the case of the pin that got stuck in the guide it had already happened to a colleague of mine but then we forgot to report it to you.The patient is fine, he has already been operated for the conversion to definitive synthesis with success, we only had a modest dilation of the operating times.The procedure, albeit with delay, was successfully completed.To overcome the retention of the pin fragment we had to vary the insertion technique (instead of using hole 2 and hole 4 as i usually do i used 1 and 5 leaving the "half hole" with the tip of the pin retained in position 3 obviously pin free).".

• Brand Name: SELF-DRILLING HALF PIN APEX Ø 5MM, 120 X 35MM
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13552448
• MDR Text Key: 288358913
• Report Number: 0008031020-2022-00055
• Device Sequence Number: 1
• Product Code: JDW
• UDI-Device Identifier: 07613327091908
• UDI-Public: 07613327091908
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K001886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/03/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: 5018-5-120
• Device Catalogue Number: 50185120
• Device Lot Number: H44619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/21/2022
• Initial Date FDA Received: 02/17/2022
• Supplement Dates Manufacturer Received: 05/06/2022
• Supplement Dates FDA Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1