MAUDE Adverse Event Report: INSTITUT STRAUMANN AG SCS SCREW DRIVER L 27MM - LONG; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number 046.402

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/26/2021

Event Type  Injury  

Manufacturer Narrative

The batch number could be verified.Our manufacturing q-system assures, that production and process controls are in place to ensure that batches confirm to the applicable specifications before they are distributed 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 reported that patient swallowed scs screwdriver 046.402 lot unknown.Initial investigation involved communication/interviews with the healthcare professional.Analysis of sales history of the customer (b)(4) indicated the lots that have been purchased by the customer which could have potentially been involved in this incident.Through a process of deduction the part involved is expected to be from either of these lots: egw32 or fck81.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 only few parts were available on stock.Informative measurements were performed these samples (3 pcs of fck81, 1 pc egw32).These indicatives measurements confirm that stock parts are within specification.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 neither lot fck81 nor egw32.No product related cause is identified.Inhalation / swallowing is an identified 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 / swallowing.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.

Event Description

Clinician reports a tooth extraction with immediate implant insertion in site fdi #15 was being conducted in male patient on (b)(6) 2021.While tightening the healing abutment, the screwdriver 046.402 scs screwdriver l 27mm ¿ long fell in the patient¿s mouth and subsequently was swallowed.The x-ray result on (b)(6) confirmed the instrument was in the caecum.On (b)(6) patient informed the dentist that the instrument is excreted.In a letter dated (b)(6), addressed to the dentist, the patient claims additional stress, bleeding, and punitive damage for which he is demanding monetary compensation from the dentist.However, no proof of these claims has been provided.

• Brand Name: SCS SCREW DRIVER L 27MM - LONG
• Type of Device: ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS
• 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: 12468930
• MDR Text Key: 271326776
• Report Number: 0009613348-2021-68399
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 046.402
• Device Lot Number: EGW32
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/14/2021
• Event Location: Other
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention