MAUDE Adverse Event Report: INSTITUT STRAUMANN AG SCS-SCREW DRIVER; ENDOSSEOUS DENTAL IMPLANT

Catalog Number 046.401

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Aspiration/Inhalation (1725)

Event Date 06/28/2021

Event Type  Injury  

Manufacturer Narrative

The scs screwdriver is a multiple use torque transmission instrument which is used to apply or transmit torque to prosthetic devices and can be used in conjunction with a ratchet.The customer initially reported that patient aspirated (inhaled) scs screwdriver 046.401 lot ehg85.Initial investigation involved communication/interviews with the healthcare professional.Analysis of sales history of the customer #12228984 indicated that the customer had identified the wrong article and lot number since the customer only received the lot number ehg85 mid january 2021 which is after the reported event date of december 16, 2020.Further investigation indicated that the actual part and lot that was involved is article 046.402 scs screwdriver, long, length 27, 0 mm, stainless steel lot apr68.The production record review conducted at the manufacturing site for this article and lot number did not identify any anomalies.Additional lot tracking was conducted which shows that all parts of lot apr68 are sold.No parts available from the same lot / batch for testing.Review of the complaints database confirms that no further complaints have been registered with this article and lot number.It can be concluded that there is no indication of an issue with 046.402 lot apr68.No product related cause is identified.Inhalation is an inherent risk of the procedure and is identified in the risk management file.The ifu 701124/y/23 states in section 5.Warnings that products must be secured against aspiration when handled intra-orally.Further it states that for multiple- use devices, the instrument must be carefully checked for proper function and damage before every use.The risk assessment covers the risk of aspiration.Mitigators are in place by design to prevent this as far as possible.This incident does not impact the severity or probability of occurrence.All of the residual risks combined are considered acceptable when balanced against the evaluated benefits provided by the device.This incident does not warrant a change in benefit risk ratio.No corrective measures are indicated.

Event Description

A (b)(6) year female patient underwent surgery on 19.07.2021 to receive 3 straumann dental implants in sites 41 (1x 021.4312 lot la690), site 43 (1x 021.4312 lot la690) and in site 46 (1x 033.612s lot lm909) together with closure screws.The implantation surgery was conducted in a separate dental practice.On (b)(6) 2020 the patient was scheduled for the prosthetic restoration of the three successfully osseointegrated implants at dental practice dr.(b)(6).The clinician attempted to position the 046.402 scs screwdriver long, length 27, 0 mm, stainless steel lot apr68 in the closure screws together with ratchet and also manually to remove them as preparation for the insertion of the prosthetic restoration of the implants.The scs screwdriver did not engage with the closure screw and kept slipping out.The scs screwdriver then fell into the patients¿ throat.The patient aspirated the scs screwdriver and had difficulty breathing.The patient was immediately taken to hospital by ambulance.The scs screwdriver was removed by bronchoscopy on the same day.The patient returned to the dental practice on (b)(6) 2020 and the prosthetic restoration of the implants was completed as planned.The incident was only reported to straumann on 28th june 2021.

Manufacturer Narrative

The scs screwdriver is a multiple use torque transmission instrument which is used to apply or transmit torque to prosthetic devices and can be used in conjunction with a ratchet.The customer initially reported that patient aspirated (inhaled) scs screwdriver 046.401 lot ehg85.Initial investigation involved communication/interviews with the healthcare professional.Analysis of sales history of the customer (b)(6) indicated that the customer had identified the wrong article and lot number since the customer only received the lot number ehg85 mid january 2021 which is after the reported event date of december 16, 2020.Further investigation indicated that the actual part and lot that was involved is article 046.402 scs screwdriver, long, length 27, 0 mm, stainless steel lot apr68.The production record review conducted at the manufacturing site for this article and lot number did not identify any anomalies.Additional lot tracking was conducted which shows that all parts of lot apr68 are sold.No parts available from the same lot / batch for testing.Review of the complaints database confirms that no further complaints have been registered with this article and lot number.It can be concluded that there is no indication of an issue with 046.402 lot apr68.No product related cause is identified.Inhalation is an inherent risk of the procedure and is identified in the risk management file.The ifu 701124/y/23 states in section 5.Warnings that products must be secured against aspiration when handled intra-orally.Further it states that for multiple- use devices, the instrument must be carefully checked for proper function and damage before every use.The risk assessment covers the risk of aspiration.Mitigators are in place by design to prevent this as far as possible.This incident does not impact the severity or probability of occurrence.All of the residual risks combined are considered acceptable when balanced against the evaluated benefits provided by the device.This incident does not warrant a change in benefit risk ratio.No corrective measures are indicated.

• Brand Name: SCS-SCREW DRIVER
• Type of Device: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; SZ 04002
• Manufacturer (Section G): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; SZ 04002
• Manufacturer Contact: jennifer jackson ; 60 minuteman road; andover, MA 01810 ; 9787472509
• MDR Report Key: 12212429
• MDR Text Key: 264083764
• Report Number: 0009613348-2021-52773
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 046.401
• Device Lot Number: W9499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/28/2022
• Event Location: Other
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male